WORLD TRADE  
ORGANIZATION  G/SPS/W/185 
31 January 2006 
 (06-0423) 
Committee on Sanitary a nd Phytosanitary Measures Original:   English 
  
 
  
IMPLEMENTATION OF ARTICLE 6 OF THE SPS AGREEMENT 
(REGIONALIZATION) 
 
Communication from Brazil
 
   The following communication, dated 27 January 2 006, is being circulated at the request of the 
Delegation of Brazil. 
 
_______________ 
 
 1. Brazil congratulates the Committee for the effort s to promote the effective application of 
Article 6 of the Agreement on the Application of Sanitary and Phyt osanitary M easures (SPS 
Agreement).  That subject, of extreme importance fo r the Members, has been discussed since the first 
Review of the Agreement, when delays for the recognition of areas with a differentiated sanitary 
status had already been highlighted.  Thus, Brazil would like to present a new proposal on this matter 
aimed at improving the previously presented document (G/SPS/W/177). 
2. In our previous document G/SPS/W/177, we pro posed the type of work that could be 
developed by the Committee in order to promote e ffective application of Article 6.  In it, we 
suggested that the Committee develop a clear definition of technical/scientific and administrative procedures involved in the recognition of pest and disease free zones.  So, we have proposed the 
elaboration, by the Committee, of objective guide lines for administrative procedures, including the 
determination of timeframes.  We  also proposed that technical/sci entific procedures should follow the 
guidelines elaborated by the International Standards Setting Bodies  (ISSBs).  We considered the 
documents of other developing countries, mainly Pe ru and Chile, in the elaboration of the mentioned 
Brazilian proposal.  When presented during the 33
rd meeting of the SPS Committee, many countries 
such as Argentina, Chile, Peru, Paraguay, Kenya and also the representative of the European 
Communities, supported that Brazilian proposal. 
3. In addition to the document G/SPS/W/177, Br azil elaborated the document G/SPS/GEN/584 
on regionalization applied to foot -and-mouth disease.  The administrative delays and the lack of 
adequacy of the requirements in relation to ISSB s recommendations were listed are amongst the main 
impediments for the effective recognition of the regi onalization and consequently for market access,.  
4. Other documents on experiences of the New castle disease regionalization (G/SPS/GEN/608) 
and Classical Swine Fever (G/SPS/GEN/609), have al ready been presented to the Committee for the 
next session.  Both indicate that OIE's recognitio n of free zones for a greater number of diseases 
and/or pests would enhance internationa l trade of animals and animal products. 
5. In this document, we present an analysis of the critical points indicated in previous 
documents, aimed at improving the Brazilian Proposal. G/SPS/W/185 
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  I. DEFINITION OF "ADMINISTRATIVE" AND "TECHNICAL/SCIENTIFIC" 
PROCEDURES 
6. Some Members, for example Japan and Canada, c onsider these two types of procedures to be 
very similar and thus difficult to differentiate.  According to Japan, the elaboration, by the SPS 
Committee, of applicable guidelines for administrati ve procedures, could duplicate the work of the 
ISSBs and cause confusion between the members (G /SPS/GEN/605).  However, we consider that the 
guidelines released by the ISSBs suggest ways of diffe rentiating between the two types of procedures.  
In our evaluation, the Terrestrial and Aquatic An imal Health Code of the World Organization for 
Animal Health (OIE), as well as the Internationa l Standards for Phytosanitary Measures – ISPMs 04, 
07, 11 and 20, listed in the Japanese document, apply to the implementation, maintenance and 
evaluation of the differentiated sanitary status of territo ries.  In this way, they relate to the procedures 
that, by nature and excellence are considered techni cal-scientific.  They do not  configure instructions 
to be applied on administrative stages of the pr ocess of recognition of regionalization measures. 
7. Japan and Canada, in their recent doc uments on regionalization (respectively 
G/SPS/GEN/605 and G/SPS/GEN/613, both of December 2005), cited the works in progress at the IPPC for the elaboration of the ISPM " Guidelines for the recognition of the establishment of free-pest 
areas and areas of low pest prevalence ".  Brazil wishes to congratulate and thank IPPC on its efforts 
related to the optimization of the recognition of fr ee zones (mainly in relation to the implementation 
of the recognition of pest-free zones, like the OIE already does for four diseases).  However, we are 
certain that the SPS Committee can, and must, el aborate its guidelines on regionalization, without 
overlapping the activities of that Convention.  We de em it convenient to consider the proposed ISPM 
guidelines in the context of the elaboration of the guidelines that should be established by the SPS 
Committee.  Despite being very pertinent, th e IPPC proposal does not contemplate important 
situations of relevance to the SPS Committee. 
8. By analyzing established processes of recognition of pest and disease free areas, it is possible 
to identify common events and to determine the essentially administrative or technical-scientific 
characteristic involved. 
9. We suggest that technical-scientific procedur es are those procedures that involve analysis 
related to the biological and/or epidemiological ch aracteristics of the disease/pest and its etiological 
agent.  The administrative procedures will be the other procedures involved. 
10. In the mentioned ISPM proposal " Guidelines for the recognition of the establishment of pest-
free areas of low pest prevalence ", the term "technical" is cited only twice in the description of the 
stages for the recognition of free zon es or low pest prevalence.  Those two citations are related to the 
responsibilities of the importing Member related to th e "technical analysis" of the information given 
to the exporter and later, for the elaboration of  a "technical justification", when refusing the 
recognition of a zone. 
11. Recognizing that the DECISION on the region alization recognition must be essentially 
technical and based on risk analysis and equivalence,  we are certain that the stages to be carried out 
are, in their majority, administrative.  Because  of that, the SPS Committee may develop guidance in 
this area, mainly in relation to deadlines. 
 
12. We consider that some points of the ISPM  proposal could improve the recognition of 
regionalization measures and must be c onsidered by the Committee, as follows: 
- Assignment of "contact points" in order to improve the communication between the parties; 
-
 Information about the date of the request’s receipt, indicating if the documentation is 
complete and whether analysis can begin; and  G/SPS/W/185 
 Page 3 
 
 
  - Description of the process that will be a dopted for the analysis of the request. 
 13. Based on the Brazilian experience and on the cu rrent work on this subject in the SPS and 
ISSB Committees, we propose the definition of the following steps for the process (Graphic plan in 
Annex I): 
A. R
EQUEST OF THE SPECIFIC QUESTIONNAIRE  TO BE SUBMITTED ON THE EVALUATION 
(EXPORTING MEMBER ADMINISTRATIVE PROCEDURES ) 
14. Usually, the soliciting exporting Member initiat es the process, sending the information on the 
adopted measures for the implementa tion and maintenance of the sanitary status of the zone to be 
recognized by the importer.  Frequently, the importing Member, receiving this information, 
immediately requests answers to a specific questionna ire, even when most of the information had 
already been given.  In order to prevent this o ccurrence, we propose that th e process starts when the 
questionnaire is requested for the evaluation .  It would make the process more objective and efficient 
by preventing the sending of information that will not be used.  In addition, this would decrease the 
delays related to additional information requests.  Those procedures in the first stage of the process 
are essentially administrative measures. 
(a) The exporting Member requests that the importing Member the specific questionnaire 
for the evaluation of its free zones; 
(b) The exporting Member will include in its requ est the references of its "contact point". 
B. SENDING TO THE EXPORTING MEMBER THE SPECIFIC QUESTIONNAIRE FOR THE ANALYSIS 
AND DETAILING ABOUT THE RECOGNITION PROCESS (ADMINISTRATIVE PROCEDURE OF THE 
IMPORTING MEMBER ) 
 S UGGESTION OF DEADLINE :  ONE MONTH AFTER RECEIVING THE REQUEST  
15. When it concerns diseases and pests that have  free zones previously  recognized by the 
Importing Member, the procedure would be merely ad ministrative since the questionnaire to be used 
must be the same one that was answered by other countries that already had their free zones 
recognized. 
16. When sending the questionnaire for analysis, the importing Member must also send 
references of its "contact point", a summary of the process including details of all the stages, as well as the evaluation criteria.  Those measures c ould improve predictability of the process. 
17. The Importing Member at this stage would be responsible for the following procedures: 
(a) The provision of the questionnaire and information about its "contact point"; 
(b) The provision of an annex detailing the administrative and technical steps; 
(c) The provision of an annex containing the evaluation criteria. 
18. When a Member has already recognized a disease- or pest-free free zone, it will notify the 
Committee, displaying the evaluation questionnaire a nd the analysis criteria.  This will allow the 
control of discrimination in the evaluation among countries and enhance transparency. 
19. Having the knowledge of that information, the others Members will be able to initiate the 
process by sending the answered questionnaire and form ally requesting the recognition of its zones.  
In that way, they would avoid having to request a specific questionnaire, accelerating the procedure. G/SPS/W/185 
Page 4  
  20. When the importing Member has never recognized  free zones of a specific pest or disease  
and thus does not have a specific form or even an evaluation methodology, the process will be initiated by the sending of information by the soliciting exporting Member.  In that case, the importing Member will inform the soliciting exporting Member of that condition. 
C. A
NSWER THE QUESTIONNAIRE FOR EVALUATION (TECHNICAL -SCIENTIFIC PROCEDURE OF THE 
EXPORTING MEMBER ) 
 S UGGESTION OF TIME FRAME :  3 MONTHS  
21. The exporting Members should also respect the ti me frame of three months for answering the 
evaluation questionnaire.  If the exporting Members do not reply to the questionnaire, the Importing 
Member may prioritize the evaluation of other requests. 
D. ANALYSIS OF THE INFORMATION SUPPLIED BY THE EXPORTING MEMBER (TECHNICIAN -
SCIENTIFIC PROCEDURE TO THE IMPORTING MEMBER ). 
 S UGGESTION OF TIME FRAME :  6 MONTHS  
22. In our opinion, this is a technical-scientific procedure that must follow, exclusively, the 
guidelines of the ISSBs.  So, the technical criteria and the form of conducting the analysis must follow 
the standards already established by the ISSBs, in  accordance with the principles of SPS Agreement.  
However, extreme delays for the conclusion of this  stage are very common, as mentioned by many 
Member Countries' documents. 
23. We understand that it is not the responsibility of  the SPS Committee to establish the technical 
criteria.  However, according to the SPS Agreement,  the Members have the obligation to adjust their 
administrative structures in order to prevent ex treme delays.  Thus, we believe the SPS Committee 
could establish time frames for the conclusion of this technical analysis. 
24. We consider that the time that is necessary for the technical analysis is directly related to 
administrative factors, such as the number of techni cians and labour conditions.  The establishment, 
by the Committee, of applicable time frames for this stage would value the efforts of the exporting 
Members in order to supply such a great amount of  information.  We emphasize that the recognition 
of regionalization measures are necessarily related to the acceptance of the measures' equivalence.  
Thus, the Decision on the Implementation of Article  4 launched by the SPS Committee must also be 
considered. 
25. As soon as the importing Member receives the documents sent by the exporting Member, it 
shall communicate if the documentation is in or der, so that the analysis can be started. 
26. At the end of this stage, the importing Member should also answer questions concerning:  
(a) Necessity of additional information; 
(b) Necessity of on-site auditing; 
(c) Suggestion of dates to the on-site auditing. 
 E. A
GREEING ON AUDITING DATES (ADMINISTRATIVE BILATERAL PROCEDURE ) 
 S UGGESTION OF TIME FRAME :  6 MONTHS  
27. After identifying the necessity of auditing, the importing Member will have to suggest a date 
for the inspections in the exporting Country.  The importing Member must conclude the inspection (auditing) in six months, after finishing the analys is of the information.  If the exporting Member  G/SPS/W/185 
 Page 5 
 
 
  cannot receive the auditing, within the stated period, it will lose the priority to other Members 
interested in having its areas recognized by the Importing Member. 
28. We stress that the auditing will have to occur in six months after the end of the analysis of the 
information by the Importing Member.  So, the members will have to set up a date in the first month 
after the identification of the need for an audit.  In order to set up the date, the Members can exchange 
electronic messages or faxes between their "contact points", or others types of communications, to 
enhance the flexibility of the process.  However, th e final communication about the settled dates must 
be done through official diplomatic means. 
F. ON-SITE AUDITING (TECHNICAL -SCIENTIFIC PROCEDURE OF THE IMPORTING MEMBER ) 
G. TRANSMISSION OF THE ANALYSIS FINAL RESULTS TO THE EXPORTING MEMBER 
(ADMINISTRATIVE PROCEDURE ) 
 S UGGESTION OF TIME FRAME :  4 MONTHS  
29. We understand that the auditing process and the ela boration of technical reports are scientific 
procedures for which we do not propose Commi ttee guidelines.  However once the auditing is 
concluded, the sending of the results to the exportin g Member becomes an administrative procedure.  
At this stage, the time taken for concluding the job by sending the results to the exporting Member 
depends on the availability of the auditors throughou t the process, from start to finish.  We also 
understand that, the non-existence of delays in this  stage depends on the commitment of the countries 
to provide access to their structures.  It is an administrative problem, not a technical one. 
H. THE EXPEDITION OF A NE W REGULATION OR CHANGES ON THE PRESENT ONE (IMPORTING 
MEMBER ADMINISTRATIVE PROCEDURE ) 
 S UGGESTION OF TIME FRAME :  2 MONTHS  
30. When necessary, the new regulation should be el aborated and sent for "public comment", in a 
maximum period of two months after the expedition of the final result of the analysis.  This stage is 
intended for document writing, based on the completed analysis.  We consider this procedure to be 
administrative, because even if the same techni cian conducts the writing of the regulation, the 
technical analysis is already finished. 
I. "PUBLIC COMMENT "  (IMPORTING MEMBER ADMINISTRATIVE PROCEDURE ): 
 S UGGESTION OF TIME FRAME :  4 MONTHS  
31. The maximum time for public comment, for inco rporating the suggestions and for sending the 
final version to sanction shall not exceed four months. 
J. RECOGNITION OF THE NORM (IMPORTING MEMBER ADMINISTRATIVE PROCEDURE ) 
 S UGGESTION OF TIME FRAME :  3 MONTHS  
32. This is the maximum time for the new regulation to  become effective.  It must be considered 
that all the administrative and technical procedures,  previously mentioned, that could demand time, 
had been already contemplated.  We believe that 3 months is a reasonable time frame for this last and 
merely administrative procedure. G/SPS/W/185 
Page 6  
  "FAST TRACK" 
 
Recognition process of free zones, already recognized by ISSBs
 
 
33. Following the proposal suggested by Colombia in its document G/SPS/GEN/611, from 
December of 2005, we also suggest that, for z ones recognized by the ISSB, the exporting Members 
would have to initiate the process by sending the same information that was sent to ISSB for its 
approval of its free zone.  
34. The importing Country, as a member of the ISSB, would only have to evaluate the necessity 
of auditing the exporting Member for evaluating on-site the given information.  As the analysis of the 
consistency of the free zone is already evaluate d by the ISSBs, discarding the necessity of same 
analysis by the importing Member, the suggested ti me frames would be established from the "step b" 
from "stage D".  Without requiring new analysis, the importing Member will have to disclose the audit necessity, and suggest dates, in the maximum period of two months after the receiving of the 
information. 
35. The recognition of these zones, already approved by the ISSBs, must receive priority 
treatment by the importing Members.  The time betw een disclosing the necessity  of an audit and its 
completion must not exceed three months. 
36. Additionally, we propose that when the importing Member considers that a higher protection 
level than the international standard is necessary,  making this "fast track" impracticable, he must 
notify the Committee and publish its evaluation crite ria, as well as the specific questionnaire for 
analysis.  This would help coun tries identify requirements that are not scientific based (graphical 
scheme on Annex II). 
Recognition of pest- and disease-free zones by ISSBs 
 
37. In document G/SPS/GEN/608, we indicate the l ack of OIE guidelines for the Newcastle 
disease zoning as one of the impediments for the importing Members' effective recognition of 
exporters' regionalization measures.  The absence of specific international standards for the 
regionalization of this disease, contributes to the re fusal of many countries to analyse the requests for 
recognition of free zones.  When they make it, ma ny countries adopt inconsis tent and unpredictable 
analytical criteria.  Because Newc astle Disease is one of the main sanitary barriers to avian products 
commerce, the absence of such guidelines causes severe damages for the exporting Countries. 
38. In the Document G/SPS/GEN/609 we noted that the OIE recognition of Classical Swine 
Fever-free zones, could facilitate the acceptance by the importing Members of measures applied to the 
regionalization of this disease in exporting count ries.  For this disease, there are specific 
regionalization guidelines. 
39. Even if the importing Members continued to in spect the free zones before approving the OIE 
recognition, OIE recognition would promote conf idence in the application of concepts of 
regionalization for these diseases.  The lack of OIE re cognition is indirectly responsible for the refusal 
of many importing Members to evaluate the free zon es from the exporting interested parties.  In some 
cases, the legislation of some Members, establish es that before being internally approved, the 
exporting countries free zones will have to be recognized by the OIE. 
40. Concluding our proposal, we are sure that th e recognition of more disease- or pest-free zones 
by the ISSBs would only be beneficial if it promot es the improvement in bilateral recognition by the 
Members.  If these international recognitions we re to represent only one more requirement to be 
fulfilled by the exporting Members, Brazil would rej ect the implementation of such recognition by the 
ISSBs.  To ensure that international recognition will promote improvements in the bilateral processes,  G/SPS/W/185 
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  the SPS Committee should formulate guidelines regard ing these concerns and recognize the exporting 
Members' efforts. 
41. We pointed out that as described in Article 6 of SPS Agreement, the implementation of pest- 
and disease-free zones, must in addition to improving  the sanitary state of the country, bring benefits 
to international commerce.  Ho wever, exporting Members are not being fully compensated for the 
large financial investments required for the impl ementation of these zones through improved market 
access by importing Members. 
 
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 G/SPS/W/185 
Page 8  
  1 month 
3 months 
6 months
6 months 
4 months 
2 months
4 months
3 monthsAnnex I 
 
Flowchart of the stages for recognizing pest- or disease-free zones 
 
 Administrative procedures 
  Technical and scientific procedures 
 
 
   
 
    
 
     
 
    
 
     
 
    
 
     
 
    
 
   
 
E- Agreeing on auditing dates D-Information analysis 
(a) ask additional data (b) ask on site auditing  
(c) propose dates for aud
iC- Supply of answers to the 
questionnaire 
F- Auditing  A- Questionnaire request: 
(a) request questionnaire 
(b) indicate "contact point" 
B- Questionnaire sending: 
(a) indicate "contact point" 
(b) detail all stages (c) inform on the evaluation criteria 
G-Sending of the final analysis result
H-Writing of the new domestic rule
I- Public comment: (a) public comment (b) add suggestions 
(c) send for approval  
J-Recognition G/SPS/W/185 
 Page 9 
 
 
  3 months 
2 months 
4 months 
3 months 3 months 3 months Annex II 
 
Flowchart of the stages for recognizing diseases or pests-free zones 
 
 Administrative procedures  
 Technical and scientific procedures 
 
 
 
3 months 
E- Agreeing on auditing dates D-Information analysis (b) ask on site auditing  
(c) propose dates for aud
iC- Supply of 
answers to the 
questionnaire 
F- Auditing  
G- Sending of the final analysis result 
H- Writing of the new domestic rule 
I- Public comment: 
(a) public comment (b) add suggestions 
(c) send for approval  
J- Recognition  
__________