G/SPS/W/311/Add.2  
 
27 June 2019  
(19-4366) Page: 1/4 
Committee on Sanitary and Phytosanitary Measures    
 
ARTICLE 6 OF THE SPS  AGREEMENT  
QUESTIONS FOR DISCUS SION  
COMMENTS SUBMITTED B Y OIE1  
Note by the Secretariat2 
Addendum  
Brazil, the European Union and the United States of America submitted a communication 
(G/SPS/W/311) , circulated on 8 March 2019, requesting Members, as well as the IPPC and OIE, to 
review a set of questions and provide comments through the Secretariat by 10 May 2019. 
Subsequently, the co -sponsors of the submission invited all interested Members , as well as the IPPPC 
and OIE,  to submit replies to the questions contained in proposal G/SPS/W/311, as well as comments 
on the questions, by  14 June 2019.  
This document provides the replies to the questions, and comments on the questions, as submitted 
by OIE. The questions in the proposal, as well as the replies received, will form the basis for 
discussions at the informal meeting on 1 7 July 2019.  
In addition to the questions addressed to IPPC and OIE in document G/SPS/W/311,  Ukraine 
submitted one question for the OIE as follows:  
▪ Whether OIE takes (will take) into account the epizootic situation, which has an impact on 
the economic component and is aimed at trade facilitation while developing regionalization 
and disease status  standards?  
This question was subsequently sent to the OIE. At the OIE's request, the Secretariat sought further 
clarification on the question from Ukraine.  
1  QUESTIONS FOR OIE RE PRESENTATIVES  
1.1.  NOTE: most OIE responses are specific to the Terrestrial Animal H ealth Code , but please note 
that regionalization  is also addressed in the Aquatic Animal Health Code.  
Has the OIE revised their regionalization and disease status standards in recent years to 
clarify or elaborate provisions in response to Members' trade co ncerns? Are there any 
future plans to further revise these standards in the future?  
1.2.  OIE standards pertaining to regionali zation and disease status are set out in the Terrestrial 
Animal Health Code (the Terrestrial Code) and the Aquatic Animal Health Code ( the Aquatic Code), 
supported by diagnostic standards in the Manual of Diagnostic Tests and Vaccines for Terrestrial 
Animals, and the Manual of Diagnostic Tests for Aquatic Animals.  
                                                
1 The compilation of comments from Members is available in document G/SPS/W/311/Add.1  and 
comments from the IPPC are available in document G/SPS/W/311/Add.3.  
2 This document  has been prepared under the Secretariat's own responsibility and  is without prejudi ce 
to the positions of Members or to their rights and obligations under the WTO.  G/SPS/W/311/Add.2  
 
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  1.3.  OIE standards may be revised because of new scientific evidence, changes in the 
epidemiological situation of diseases or comments from m ember countr ies. 
1.4.  At the end of each chapter of the Codes and Manuals you can find when the chapter was first 
adopted and  when it was last amended. For example, the Terrestrial Code, Chapter 4.3. on Zoning 
and compartmentalisation was first adopted in 1998 and last amended in 2018; Chapter 4.4. on the 
Application of compartmentalisation was first adopted in 2008 and last ame nded in 2012. The 
Aquatic Code, Chapter 4.1. on Zoning and compartmentalisation was first adopted in 1995 and last 
amended in 2010; Chapter 4.2. on the Application of compartmentalisation was first adopted in 2010 
and last amended in 2016.  
1.5.  The rational and  details of amendments of new or revised standards adopted in the Codes and 
Manuals each year can be found in the respective reports of the Terrestrial Animal Health Standards 
Commission (Terrestrial Code), Biological Standards Commission (Terrestrial Manu al) and Aquatic 
Animals Commission (Aquatic Code and Manual) made at the OIE General Session, which are publicly 
available at the OIE website ( http://www.oie.int /en/about -us/key -texts/final -reports -of-the-
general -session/ ). More detailed information regarding the development of these new and revised 
chapters is available in the respective reports of the Specialist Commissions which are available at: 
http://www.oie.int/en/standard -setting/specialists -commissions -working -ad-hoc-groups/ . 
1.6.  The future revision of OIE standards is defined by the work programme of the Spec ialist 
Commissions, which are published as part of the Commissions ' meeting report s. The last version of 
these programmes can be found as part of the February 2019 meeting report of each Commission, 
available at the OIE website ( http://www.oie.int/en/about -us/wo/commissions -master/ ). 
How are standards on surveillance linked to effective implementation of these standards?  
1.7.  The chapters in Section 1 of the Terrestrial Code are designed for the implementation of 
measures for the surveillance and notification of pathogenic agents. Chapter 1.4. on Animal health 
surveillance provides general recommendations on surveillance aimed at demonstrating the absence 
of disease or infection, determining t he presence or distribution of disease or infection or detecting 
as early as possible exotic or emerging diseases. This guidance should be used when specific 
provisions are not included in disease -specific chapters.  
1.8.  Section 1 of the Terrestrial Code also includes information on the Procedures for self -declaration 
and for official recognition by the OIE (Chapter 1.6.) and standards for the application of official 
recognition by the OIE of free status for African horse sickness, bovine spongiform encephalopa thy, 
foot and mouth disease, contagious bovine pleuropneumonia, peste des petits ruminants and 
classical swine fever.  
1.9.  The level of detail regarding recommendations for surveillance and the assessment of health 
status of a country, zone or compartment varie s amongst disease -specific chapters.  
Are there other underlying key standards that are pre -requisite and essential in order to 
implement successfully regionalization?  
1.10.   OIE's presentation to the WTO SPS Committee Thematic Session on Regionalization  in 2017 
fully outlined the relevant standards and the implementation challenges associated with 
regionalization  (https://www.wto.org/english/tratop_e/sps_e/wkshop11july1 7_e/stone.pdf ). 
1.11.   Implementation of successful regionalization  is complex and elements essential for 
implementation are described in many different sections of the Codes. For example, chapters of 
Section 3 of both Codes are designed for the establishment, ma intenance and evaluation of 
Veterinary Services and Aquatic Animal Health Services, respectively, and for communication, and 
in the case of the Terrestrial Code, also veterinary legislation. Many aspects of a quality Veterinary 
Service would be considered as essential for successful implementation of regionalization . 
1.12.   In addition to provisions in disease -specific chapters, some specific chapters to consider in 
the Terrestrial Code include Chapter 1.1. Notification of diseases, infections and infestations, an d 
provision of epidemiological information, Chapter 4.3. Zoning and compartmentalisation and G/SPS/W/311/Add.2  
 
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  Chapter  4.4. Application of compartmentalisation. Note there are equivalent chapters in the Aquatic 
Code.  
1.13.   Please note that depending on the disease, and whether it  is officially recognized  by the OIE, 
and the nature of the commodity , many other chapters may also need to be considered.  
1.14.   Complying with the relevant diagnostic standards in the Aquatic and Terrestrial Diagnostic 
Manuals are also required to fulfil some r equirements.  
Are there any plans to expand standards and procedures on recognition of disease -free 
status of member countries?  
1.15.   The OIE does not have plans to include additional diseases as part of the OIE official 
recognition procedure.  
1.16.   The OIE also endo rses OIE member countries ' official control programmes for foot and mouth 
disease, contagious bovine pleuropneumonia and peste des petits ruminants. Dog -mediated rabies 
will be included starting from 2020.  
1.17.   The OIE has developed Standard Operating Procedure s (SOPs) to assist Members with the 
process relating to the official recognition of a specific disease status, for the official recognition of 
a risk status for bovine spongiform encephalopathy (BSE) or for the endorsement of a national 
official control pr ogramme. The SOPs currently apply to the official recognition of disease status for 
six OIE -listed terrestrial animal diseases, namely: African horse sickness, classical swine fever  (CSF) , 
contagious bovine pleuropneumonia, foot and mouth disease  (FMD) , peste des petits ruminants  
(PPR)  and for BSE risk status.  
1.18.   OIE Members also have the possibility to self -declare their country or, a zone or a 
compartment within their territory, free from any disease. Should Members submit a request, the 
OIE offers to publis h these self -declaration(s)  on its website. However, the OIE will not publish self -
declarations of freedom related to those diseases for which the OIE has put in place a specific 
procedure for official recognition of disease status.  
How can OIE contribute to transparency on the use of the international regionalization 
standards?  
1.19.   Since 1998, the OIE has the mandate from the WTO to officially recogni ze disease -free areas 
of countries for trade purposes. The OIE has a procedure for the official recognition of  disease status, 
a voluntary process, that applies to six diseases: African horse sickness, Foot and mouth disease, 
Bovine spongiform encephalopathy, Peste des petits ruminants, classical swine fever, contagious 
bovine pleuropneumonia and rinderpest.  
1.20.   A list of member countries with an official disease -free status are available on the OIE website 
at: http://www.oie.int/en/ animal -health -in-the-world/official -disease -status/official -recognition -
policy -and-procedures/ . 
1.21.   Member countries may wish to make a self -declaration as to the freedom of a country, zone 
or compartment from an OIE listed disease or from other animal disease s. The member country may 
inform the OIE of its claimed status and the OIE may publish the claim. Publication does not imply 
endorsement of the claim. A list of OIE member countries that have met the OIE SOP for self -
declaration are available at: http://www.oie.int/en/animal -health -in-the-world/self -declared -
disease -status/ . 
Are there plans for developing any further materials or activities to enhance 
implementati on of existing standards related to regionalization?  
1.22.   Although not a disease subject to the OIE Official Recognition Procedure, OIE intends to 
develop regionalization  and compartmentalisation guidance specific to African swine fever, reflecting 
the interna tional priority associated with this disease and in accordance with Resolution 33 passed 
during the 87th General Session.  G/SPS/W/311/Add.2  
 
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  1.23.   Also available on the OIE website is a Checklist on the Practical Application of 
Compartmentalisation  at: 
http://www.oie.int/fileadmin/Home/eng/Our_scientific_expertise/docs/pdf/A_CMP_Checklist.pdf . 
1.24.   The OIE conducts regional training workshops on standards related to zoning and 
compartmentalisation according to the needs of member  countries. Workshops have already been 
conducted on the implementation and application for disease -free zones (for FMD, CSF and PPR) and 
for containment zones in response to an outbreak. These workshops  serve member countries in 
strengthening their knowledge on the principles for defining, establishing and maintaining zones 
complying to OIE standards. It also provides opportunities for member countries to share successful 
experiences and challenges encou ntered in establishing disease -free zones.  
2  QUESTIONS FOR MEMBER S AND IPPC AND OIE R EPRESENTATIVES  
Are there ways for the SPS Committee to collaborate more effectively with OIE to 
strengthen implementation of international standards on regionalization and Article 6?  
2.1.  The OIE standards are science -based standards that have been developed and adopted by the 
World Assembly of Delegates, comprising the 182 OIE member countries . These standards include 
many provisions and guidance for the implementation of region alisation. Each OIE member country 
is represented by an OIE Delegate. The OIE suggests SPS Committee members work with their OIE 
Delegate on these matters and engage in the OIE standard setting process.  
2.2.  Recently the OIE has undertaken an analysis of SPS no tifications received through the WTO 
SPS notification mechanism. This work was undertaken in the context of the design of the OIE 
Observatory, which also intends to use this information on an ongoing basis. We found the data very 
difficult to analyse, due to data structure, format and quality issues associated with the reporting 
mechanism. We believe the WTO SPS Committee should re -examine this system, with a view to 
improving the utility of the reported data.  
How have Members without elaborate SPS programm es relied on OIE work to facilitate 
safe importation of needed food products?  
2.3.  The Aquatic and Terrestrial Codes both include provisions for trade in ‘safe ' commodities, i.e. 
commodities that can be traded without import conditions regardless of exporting c ountry 's disease 
status.  
2.4.  In addition, the OIE 's PVS Pathway is a capacity building mechanism to assist countries in 
implementation of OIE standards.  
 
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