G/SPS/W/311/Add.1/Rev.1  
 
1 July 2019 
(19-4402) Page: 1/16 
Committee on Sanitary and Phytosanitary Measures    
 
 
ARTICLE 6 OF THE SPS  AGREEMENT  
QUESTIONS FOR DISCUS SION  
COMPILATION OF COMME NTS SUBMITTED BY MEM BERS1 
Note by the Secretariat2 
Revision  
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.  
Japan  requested clarifications to one of the questions con tained in the proposal. Specifically, t he last 
question addressed  to Members in para. 3(a) of proposal G/SPS/ W/311 which reads:  
▪ "How do you use IPPC/OIE official pest - or disease -free country or zone status in 
implementing Article 6? In your efforts to seek recognition by another Member or Member(s), 
have you found that OIE or IPPC standards are interpreted and applied consistently? Are 
there areas where additional clarification in the international standards or guidelines would 
be beneficial?"  
In respon se, the co -sponsors clarified the following:  
▪ The first sentence of the question should be clarified to read: "How do you as an importing 
country  use IPPC/OIE official pest - or disease -free country or zone status of an exporting 
country  in implementing Arti cle 6? ..." 
▪ The second sentence intends to ask whether an exporting Member has found the same 
international standard interpreted differently by its trading partners (e.g. importing 
Members).  
This document provides a compilation of the replies to the questio ns, and comments on the 
questions, as submitted by  the following  Members : Brazil; Canada; China; the European Union; 
Hong Kong, China; Japan; Mexico; Chinese Taipei; and Ukraine . The questions in the proposal, as 
well as the replies received, will form the  basis for discussions at the informal meeting on 
17 July 2019.  
                                                
1 Comments submitted by the OIE and IPPC are available in documents G/SPS/W/311/Add.2 and 
G/SPS/W/311/Add.3, respectively.  
2 This document  has been prepared under the Secretariat's own responsibility and  is without prejudice 
to the positions of Members or to their rights and obligations under the WTO.  G/SPS/W/311/Add.1/Rev.1  
 
- 2 - 
 
  1  QUESTIONS FOR MEMBER S 
1.1  Brazil  
What are your domestic procedures for establishing and maintaining pest - or disease -free 
status?  
1.1.  The procedures followed by the Brazilian sanitary authority for the establishment and 
maintenance of disease -free areas or zones are based on those established by the OIE Terrestrial 
Code, Chapter 4.3 and on specific chapters for diseases with zoning.  
1.2.  Following these regulations, the internal rules for the establishmen t of regionalization and the 
rules for the transit of animals and products are published. The main procedures are:  
▪ The extension and geographical limits of an area are clearly established by the Veterinary 
Authority on the basis of natural, artificial or l egal limits and made public through official 
channels.  
▪ Herds belonging to subpopulations of disease -free areas or zones should be recognizable 
through clear epidemiological separation of other animals and all other risk factors.  
▪ Measures to ensure identifi cation of the sub -population and to establish and maintain their 
health status through a biosafety plan are clearly documented and adequate to the eco -
productive and epidemiological characteristics of the sub -population, including surveillance, 
movement co ntrols, use of natural, artificial, or legal limits, spatial separation of animals, 
control of fomites and commercial practices of handling and management.  
▪ Relevant goods must be identified in such a way that their movements are traceable and 
well document ed and controlled.  
▪ For compartmentalization, the biosafety plan should describe the partnership between 
private sector and the Veterinary Authority, as well as their respective responsibilities. It 
should also describe the standard operational procedures i n order to provide clear evidence 
that surveillance, animal identification and traceability system and management practices 
are appropriate to meet the compartmentalization definition. The biosafety plan should 
describe how the measures will be audited to ensure that risks are managed and reassessed 
regularly, and that the measures are adjusted accordingly.  
What challenges have you encountered in implementing such procedures?  
1.3.  Regionalization is a very important principle for animal health management in Braz il, 
considering the large territorial extension and the geographical and environmental diversity in 
Brazilian territory. These factors represent major challenges, since they require large investments 
in livestock registration controls and movement of anima ls and products, with a view to guaranteeing 
adequate regionalization conditions. There is a need for strong structures and procedures by the 
veterinary services and for disease surveillance, including the early detection of diseases and also 
the demonstra tion of absence of infectious agents, as a way of ensuring the sanitary condition and 
the certification of goods from zones or regions.  
1.4.  In addition to these, another major challenge is to obtain recognition of disease -free zones or 
areas from importing cou ntries, which often do not consider a recognition of health status from OIE, 
demanding efforts and costs to answer questionnaires from importing countries and organize 
missions and audits, sometimes without justified technical reasons.  
What kind of Committ ee activities and documents are most useful to you in your domestic 
consultations on implementation of Article 6?  
1.5.  In the case of animal health, the Department of Animal Health of the Ministry of Agriculture, 
Livestock and Supply (DSA/MAPA) routinely applie s the guidelines of the relevant international 
organizations, particularly the Terrestrial Code and other documents of the OIE. In that sense, it has 
not yet specifically used the documents published by the SPS Committee.  G/SPS/W/311/Add.1/Rev.1  
 
- 3 - 
 
  Have you used the Committee's Guid elines on Regionalization (G/SPS/48) in your efforts 
to seek recognition by another Member of your domestic control and enforcement systems 
for establishing and maintaining pest - or disease -free status?  
1.6.  In the case of animal health, the Department of Anima l Health of the Ministry of Agriculture, 
Livestock and Supply routinely applies the guidelines of the relevant international organizations, 
particularly the Terrestrial Code and other documents of the OIE, as well as guidelines from the 
IPPC. In that sense , the Ministry of Agriculture, Livestock and Food Supply (MAPA) has not yet used 
the Guidelines on Regionalization (G/SPS/48) in its efforts to recognize disease - and pest -free areas 
in other countries.  
Are there areas of the Guidelines that could be impro ved?  
1.7.  The procedures for the recognition of disease - and pest -free areas by importing countries 
should be harmonized with the procedures for recognition of regionalization status by the OIE and 
the IPPC, thus avoiding duplicate efforts by member countries i n order to recognize disease -free 
areas. In the case of  OIE official disease -free country or zone status, member countries should 
recognize the status granted by OIE.  
How do you use IPPC/OIE official pest - or disease -free country or zone status in 
implemen ting Article 6? In your efforts to seek recognition by another Member or 
Member(s), have you found that OIE or IPPC standards are interpreted and applied 
consistently?  
1.8.  In the case of OIE official disease -free country or zone status, Brazil considers that most of the 
standards adopted by the Terrestrial Code and other OIE documents are properly interpreted and 
implemented by Brazil for the establishment of regionalization and safe trade in food.  
1.9.  These standards are always undergoing a revision process, with  broad consultation and 
participation of the member countries, allowing advances in procedures and standards for trade. 
However, there are discrepancies in interpretation by countries and economic blocs. For example, 
some countries or blocs do not accept t he health status recognized by the OIE for disease -free 
countries or zones.  
Are there areas where additional clarification in the international standards or guidelines 
would be beneficial?  
1.10.   The procedures for countries' recognition of regionalization in what regards disease - and pest -
free areas should always be improved with the participation of importing and exporting countries.  
1.2  Canada  
1.11.   Canada considers the topic of regionalization one that is important and timely. Canada 
submitted a paper (G/SPS/GEN/1650 ) to the Committee on its experiences and approaches to 
regionalization relating to animal diseases in October 2018. Canada supports the continued 
discussion of regionalization by the Committee, in particular through the questions for discussion 
identified  in the proposal from Brazil, the European Union, and the United States of America in 
G/SPS/W/311. Canada looks forward to engaging in a focused discussion based on these questions 
at the July 2019 informal meeting of the Committee.  In advance of the July 2019 informal, Canada 
submits the following summary of its approach to regionalization.  
Animal health  
1.12.   To prevent the spread of diseases and maintain international trade, Canada manages animal 
health risks by determining if zones are required based on the unique circumstances of each disease 
situation. Some factors that Canada includes in this determination are the nature of the disease, 
presence of the disease in wildlife or the environment, potential for disease spread and geographical 
features in the are a (i.e., waterways, roads, terrain). Zoning is one tool within a suite of measures 
that Canada uses to respond to animal diseases domestically.  G/SPS/W/311/Add.1/Rev.1  
 
- 4 - 
 
  Plant health  
1.13.   Pest free areas (PFAs) are a tool within a suite of measures that Canada uses to domestically 
manag e plant health risks and to maintain trade by preventing the spread of pests. For each 
situation, Canada determines if the establishment of pest free areas or areas of low pest prevalence 
is applicable based on the results of pest risk analyses and domesti c surveys. Canada takes measures 
for the implementation of pest free areas or areas of low pest prevalence based on the relevant 
standards, guidelines, or recommendations adopted by the International Plant Protection Convention 
such as the International St andard for Phytosanitary Measures (ISPM) 4 Requirements for the 
establishment of pest free areas  and ISPM 8 Determination of pest status in an area . 
1.3  China  
How do you use IPPC/OIE official pest - or disease -free country or zone status in 
implementing Article  6? 
1.14.   As a member of IPPC and OIE, China always respects and actively implements the rules and 
standards of IPPC and OIE relating to the Article 6. Based on the guiding principles and official 
recognition of OIE, China has recognized foot and mouth (FMD) free ar eas of some Members after 
scientific assessment.  
1.15.   Regarding the control and management of animal disease, China has been applying the 
regionalization instrument in accordance with the guiding principles of OIE and promoting continuous 
innovation in light of  China 's actual situation. In this regard, China has formulated and promulgated 
the construction requirements for establishing FMD free zone of vaccination. The construction of 
FMD free zones of some Members has been accomplished and some of them have been  recognized 
as FMD -free zone s by China after scientific assessment. Consultations with other Members on a 
memorandum of cooperation on the construction of FMD -free zones are under way.  
1.16.   In accordance with the OIE guiding principles, regionalization should a lso be treated and 
applied scientifically. For disease s of avian influenza and African Swine Fever etc., which are very 
difficult to be prevented from spreading by natural physical barriers, Members should be cautious to 
apply the regionalization managemen t method.  
1.4  European Union  
What are your domestic procedures for establishing and maintaining pest - or disease -free 
status? What challenges have you encountered in implementing such procedures?  
1.17.   Within the European Union,  goods, including live animals, plants , products of animal and plant 
origin, move freely among the EU member States. The relevant legislation (animal health, plant 
health, food safety) is harmonized  at European Union level, it is legally binding for all the EU member 
States and lays down the r equirements for intra -community trade, placing on the EU market and 
imports.  
1.18.   The European Commission, based on the information received from the EU member States  
and verified via on -site audits, takes regionalization  measures, including the establishment and 
maintenance of pest - and disease -free status, in a science -based, harmonized  and transparent way.  
1.19.   The criteria for regionalization  are based on relevant international standards (OIE, IPPC) in 
line with Article 6 o f the SPS Agreement. The disease status and related trade restrictions are 
published in the Official Journal of the E uropean Union in the form of a Commission Decision that is 
legally binding and immediately applicable.  
1.20.   As an example, for ASF the overarchi ng piece of legislation providing the tool for the control 
of African swine fever in the E uropean Union is Council Directive 2002/60/EC of 27 June 2002. Within 
this framework, Commission Implementing Decision 2014/709/EU of 9 October 2014 covers the 
latest  specific regionalization  measures taken with respect to evolution of the African swine fever G/SPS/W/311/Add.1/Rev.1  
 
- 5 - 
 
  (ASF) in the E uropean Union. This is complemented by working document SANTE/7112/2015,3 which 
present s in a transparent manner guiding principles for the applicat ion of such regionalization 
measures and has been developed to lay down the principles and criteria for geographically and 
temporally defining ASF regionalization . 
1.21.   The animal and plant health situation in the E uropean Union is periodically and frequently 
monitored through the Standing Committee on Plants, Animals, Food and Feed (PAFF) which plays 
a key role in ensuring that EU measures on food and feed safety, animal health and welfare as well 
as plant health are relevant, practical and effective. The PAFF Committee delivers opinions on draft 
measures that the Commission intends to adopt.4 It is composed by representatives of all 
EU countries and presided by a European Commission representative. The PAFF Committee's 
mandate covers the entire food supply chai n - from animal health issues on the farm to the product 
on the consumer's table - helping the European Union to deal effectively and timely with health risks 
at every stage of the production chain and changes as and when needed.  
1.22.   An overview of the EU regionalization  system for animal health based on the example of Avian 
Influenza was presented at the thematic session on regionalization of July 2017. The presentation 
is available on the WTO SPS website.5 Previously, a description of the application of Article 6 as 
regards animal diseases was presented by the E uropean Union in document G/SPS/GEN/1159 of 
26 June 2012.  
1.23.   The basic EU plant health legislation (Regulation (EU) 2016/2031) deals with regionalizati on 
in the plant health area in relation to both the intra -Community trade and importation to the 
European Union. An overview of the EU system for regionalization  in relation to plant health was 
presented at the thematic session on Pest -Free Areas of Februa ry 2018. The presentation is available 
on the WTO SPS website.6 
What kind of Committee activities and documents are most useful to you in your domestic 
consultations on implementation of Article 6?  
1.24.   All documents and activities of the SPS Committee are useful for the Commission services in 
their regulatory activities. Thematic discussions on animal and plant health issues, whether general 
or specific, are also very helpful in informing the EU regulatory activities in these areas and to learn 
about other Members ' systems and procedures.  
Have you used the Committee's Guidelines on Regionalization (G/SPS/48) in your efforts 
to seek recognition by another Member of your domestic control and enforcement systems 
for establishing and maintaining pest - or disease -free status?  Are there areas of the 
Guidelines that could be improved?  
1.25.   The Guidelines are used regularly and systematically when the E uropean Union and its 
Member States are seeking recognition and maintenance of the pest - or disease -free status of the 
European Union and/or certain parts of it for the purpose of export. The WTO SPS provisions and 
relevant guidelines are also taken into account when the European Union  negotiates SPS provisions 
with other trade partners (free trade agreements or other sanita ry/phytosanitary agreements).  
1.26.   The Guidelines, together with the specific OIE and IPPC standards, are generally considered 
as a good and clear basis for negotiations with trading partners on market access related issues, 
although on many occasions the proce dure turned out to be slow and cumbersome. The E uropean 
Union's  experience is that the expedited process described under chapter IV of the guidelines is 
rarely used by some Members. In addition, the entire procedure for establishing pest and 
disease -free areas needs to be repeated after every outbreak, even when it is an outbreak of  the 
same disease under similar circumstances.  
                                                
3 https://ec.europa.eu/food/sites/food/files/animals/docs/ad_control -measures_asf_wrk -doc-sante -
2015-7112.pdf . 
4 For more information se e Comitology Register 
http://ec.europa.eu/transparency/regcomitology/index.cfm?do=OpenData.list . 
5 https://www.wto.org/english/tratop_e/sps_e/wkshop11july17_e/gavinelli.pdf . 
6 https://www.wto.org/english/tratop_e/sps_e/wkshop27feb18_e/arijs.pdf . G/SPS/W/311/Add.1/Rev.1  
 
- 6 - 
 
  1.27.   The E uropean Union is of the view that the guidelines do not need modification/improvement. 
Instead, what is required is their ap propriate implementation by all Members.  
How do you use IPPC/OIE official pest - or disease -free country or zone status in 
implementing Article 6? In your efforts to seek recognition by another Member or 
Member(s), have you found that OIE or IPPC standards are interpreted and applied 
consistently? Are there areas where additional clarification in the international standards 
or guidelines would be beneficial?  
1.28.   The E uropean Union's experience as an importing Member:  
1.29.   There is detailed legislation on the criteria  of approval of a country or part of the country for 
import of live animals, plant and products to the European Union and the sanitary requirements to 
be met.7 It is regularly revised in light of the animal health, plant health and food safety situation of  
the exporting country.  
1.30.   The application of regionalization  requires confidence in the other Member 's measures and 
policies on controlling animal and plant diseases. Previous knowledge on the animal and plant health 
situation in the given Member and the cap acity to control and eliminate the disease outbreaks are 
determining factors. The main principle is that imported goods have to meet the same criteria as 
the ones produced in the E uropean Union. 
1.31.   For plant health, the European Union accepts declarations from other Members on the pest 
free status provided they are based on IPPC standards. For animal health, the European Union asks 
for documentary evidence and carries out an evaluation both on paper and if appropriate in the form 
of on the spot audits.  
1.32.   The European Union recognizes  the regionalization  principle vis -à-vis trade partners with the 
objective of allowing trade to continue from disease -free areas, whilst restricting trade from affected 
areas. Thus, safe trade is maintained whi lst risk of spread of disease is minimized . 
1.33.   The E uropean Union's experience as an exporting Member:  
1.34.   The European Union has a mixed experience as an exporting Member; only a few Members 
recognize  fully the EU regionalization  principles and measures; others only apply the regionalization  
principles partially and sporadically vis -à-vis the European Union or do not apply them directly. 
Consequently, when a major disease outbreak occurs in a member State of the European Union, 
trading partners ban the exports of  relevant products from the entire territory of an affected member 
State, instead of targeting the affected area alone. Moreover, such a countrywide trade ban is often 
kept in place for several years without taking into account the improvements in the heal th status of 
the country/region there is no automatic re -opening after the country/region is declared free from 
the disease. Other trading partners apply regionalization  principles partially (only for some 
diseases/ member States) and/or very slowly.  
1.35.   The E uropean Union will continue asking trading partners to recognize  the regionalization  
measures as implemented in the E uropean Union and thus to allow trade from areas not affected 
with animal diseases.  
1.36.   International standards:  
1.37.   The OIE Terrestrial Animal Hea lth Code and the IPPC standards together with the WTO SPS 
Regionalization  Guidelines are clear and provide a good basis for assessing trading partners ' 
regionalization  measures.  
                                                
7 https://trade.ec.europa.eu/tradehelp/sanitary -and-phytosanitary -requirements . G/SPS/W/311/Add.1/Rev.1  
 
- 7 - 
 
  1.5  Hong Kong, China  
What are your domestic procedures for establishing and mainta ining pest - or disease -free 
status? What challenges have you encountered in implementing such procedures?  
1.38.   The Department of Agriculture, Fisheries and Conservation (AFCD) is the competent authority 
of Hong Kong, China for the control of animals, plants and  their products (except food products 
which is under the jurisdiction of Food and Environmental Hygiene Department). AFCD follows the 
recommendations of OIE with regards to reporting of animal diseases that are detected in the local 
territory, imposing san itary controls to prevent the introduction of diseases and pathogens, 
enhancing the veterinary services (such as laboratory for equine disease testing, development of 
testing for exotic disease such as African Swine Fever), proposal of enhancing animal wel fare 
standards through legislation.  
1.39.   There is legislation in place to ensure the report of notifiable diseases, import control of 
animals/plants and their products. There are also veterinary inputs (both from AFCD and veterinary 
consultants), liaison with O IE/ overseas competent authorities related to animal diseases to ensure 
AFCD is kept up -to-date with the local and global disease status. On the request by the importing 
countries/places, the overseas competent authori ties are also invited for inspection a nd other 
relevant procedures to demonstrate the disease -free status of animals (e.g. racehorses) in 
Hong Kong, China. 
What kind of Committee activities and documents are most useful to you in your domestic 
consultations on implementation of Article 6?  
1.40.   AFCD 's mainly referred to the established OIE Terrestrial Animal Health Code, Terrestrial 
Manual in the development of import requirements for animals and animal products. The World 
Animal Health Information System of OIE is also referred to for world -wide dis eases situation.  
Have you used the Committee's Guidelines on Regionalization (G/SPS/48) in your efforts 
to seek recognition by another Member of your domestic control and enforcement systems 
for establishing and maintaining pest - or disease -free status?  Are there areas of the 
Guidelines that could be improved?  
1.41.   No. 
How do you use IPPC/OIE official pest - or disease -free country or zone status in 
implementing Article 6? In your efforts to seek recognition by another Member or 
Member(s), have you found that OIE or IPPC standards are interpreted and applied 
consistently? Are there areas where additional clarification in the international standards 
or guidelines would be beneficial ? 
1.42.   AFCD does consider the OIE official disease -free status in drafting import term s for various 
live animals from different member countries. In exercising Article 6 of the SPS Agreement, AFCD 
takes into account the OIE disease -free country or zone status of an exporting country in deriving 
the import requirements of different animal sp ecies.  
1.43.   On the phytosanitary side, AFCD recognizes 'pest free areas ' and 'areas of low pest 
prevalence ' established under various relevant International Standard for Phytosanitary Measures 
(ISPMs) (e.g. 4, 8, 10, 22, 26) as guided by the ISPM29 (Recognition  of pest free areas and areas 
of low pest prevalence).  These ISPMs produced by the Commission on Phytosanitary Measures of 
the IPPC are well written and no further clarifications are required. Nonetheless, no exporting country 
has ever claimed pest -free or  low pest prevalence status when exporting plant commodities to Hong 
Kong, China and vice versa.  G/SPS/W/311/Add.1/Rev.1  
 
- 8 - 
 
  1.6  Japan8 
Japan's comments  
1.44.   Before concluding whether the guidelines on regionalization (G/SPS/48) are to be reviewed 
or not, Japan suggests for Members to check and discuss how the existing guidelines have been 
used in particular regionalization endeavors and whether the guidelines have actually been applied 
bilaterally because once we go into the detail of review of the guidelines, we could spend 
considerable tim e and resources to complete this activit y. 
Japan's enquiries  
1.45.   About the last question for Members : "How do you use IPPC/OIE official pest - or disease -free 
country or zone status in implementing Article 6? In your efforts to seek recognition by another 
Membe r or Member(s), have you found that OIE or IPPC standards are interpreted and applied 
consistently? Are there areas where additional clarification in the international standards or 
guidelines would be beneficial?"  
▪ (Question 1) Is the 1st sentence of this q uestion intended to be answered from the standpoint 
of export ing countries, instead of importing countries?  
▪ (Question 2) Could you clarify the inten tion of the 2nd sentence of the same question? Please 
clarify whether this question is asking if : 
1) An exporti ng Member has found the same international standard interpreted 
differently by its trading partners (e.g. importing Members) ? or  
2) An exporting Member has found that an importing Member interprets the same 
international standards differently in some cases ? 
What are your domestic procedures for establishing and maintaining pest - or disease -free 
status? What challenges have you encountered in implementing such procedures?  
1.46.   Concerning animal health, Japan recovers the disease -free status o f the whole country after 
the occurrence of Foot and Mouth Disease (FMD) and Avian Influenza (AI) by implementing the 
countermeasures according to the criteria for recovering the disease -free status of OIE code.  
1.47.   For instance, FMD occurred in Miyazaki Prefecture  in April 2010, which was the first case in 
Japan for the last 10 years. Because the rapid spread of the disease was observed in  the eastern 
part of the Prefecture despite the implementation of the movement restriction and stamping -out 
policy , over 210 tho usand animals were culled eventually. Emergency vaccination was applied for 
the first time in Japan to contain the rapid spread in the zone (87 thousand animals were vaccinated 
and slaughtered). And then, Japan recovered the status of FMD free country wher e vaccination is 
not practiced in February 2011.  
1.48.   In regard of plant health, the movement of pests and their hosts from the limited infested 
area in Japan, African Giant Snails in Ryukyu islands for example, is restricted. Where pests that are 
newly introdu ced in Japan or that already occur in a part of Japan potentially cause enormous 
damage to farm crops, or are considered to prevent the export of plant from Japan, they are subject 
to official control, including surveillance of the pest occurrence, restric tion on the host plants 
movement, and destruction of the host plants to contain or eradicate the pests. Japan succeeded in 
eliminating Oriental fruit flies and Melon flies from  the whole country, and still maintains free status 
of both pests.  
                                                
8 Japan provided two submissions, the first submission included general comments, as  well as a request 
for clarification of one of the questions. Please refer to  the introductory  paragraphs of this document for the 
clarification provided by the co -sponsors. The second submission responded to the questions indicated in 
G/SPS/W/311.  G/SPS/W/311/Add.1/Rev.1  
 
- 9 - 
 
  What kind of Committee activities and documents are most useful to you in your domestic 
consultations on implementation of Article 6?  
1.49.   For domestic and international transparency purposes, standard procedures for approval for 
import of products from other countries ha ve been developed , taking into account the Guidelines on 
Regionalization (G/SPS/48), as well as relevant international standards such as Import Risk Analysis 
(Terrestrial Animal Health Code Chapter 2.1) of OIE.  
1.50.   International standards of OIE and IPPC are cited more often in domestic consultation 
regarding approval of import s of specific products from other countries than SPS Committee 
documents.  
Have you used the Committee's Guidelines on Regionalization (G/SPS/48) in your efforts 
to seek recognition by an other Member of your domestic control and enforcement systems 
for establishing and maintaining pest - or disease -free status?  Are there areas of the 
Guidelines that could be improved?  
1.51.   Japan requests the importing country to inform us of the necessary proces s and the 
requirements to enable the export of Japanese products to the country in accordance with the 
Guidelines on Regionalization (G/SPS/48).  
How do you use IPPC/OIE official pest - or disease -free country or zone status in 
implementing Article 6? In you r efforts to seek recognition by another Member or 
Member(s), have you found that OIE or IPPC standards are interpreted and applied 
consistently? Are there areas where additional clarification in the international standards 
or guidelines would be beneficia l? 
1.52.   Instead of answering part of the risk assessment questionnaire from Japan (e.g. information 
on the disease outbreaks and responses taken during the past cases), the exporting country may 
use the dossier submitted to the OIE for application for recogniti on of animal disease free status. As 
for plants, IPPC does not officially recognize pest free status.  
1.53.   Regarding the question of the second sentence, the Japanese authority does not possess 
sufficient information to compare each country 's interpretation o f the international standards.  
1.54.   Lastly, the Japanese Government views that capacity building activities for Members, creating 
manuals or training materials that help establishing and maintaining the disease or pest free areas 
in accordance with the OIE or IP PC standards, for instance, and information -sharing on how the 
guideline is actually applied by Members would greatly contribute, rather than its further clarification 
and detailing, in order to promote implementation of regionalization.  
1.55.   The IPPC Internati onal Symposium for Pest -Free Areas and Surveillance held in Japan in 
October this year is one of such activities that aim to better understand pest-free areas  and to 
develop the ability of Members.  
1.7  Mexico  
What are your domestic procedures for establishing and maintaining pest - or disease -free 
status? What challenges have you encountered in implementing such procedures?  
1.56.   For animals:  We have a technical evaluation procedure for the recognition of animal 
disease -free and pest -free zones, which falls within the  scope of the general public. This procedure 
was established in accordance with national laws and following the recommendations of the 
Terrestrial Animal Health Code - World Organization for Animal Health (OIE), Chapter 4.3.  
1.57.   Actions taken to maintain disease - or pest -free zones are based on the recommendations 
issued by the OIE in the Terrestrial Animal Health Code and the requirements contained in national 
legislation (release agreements and campaign -related laws). There is a federal budget for 
mainta ining these zones. These funds are intended for implementing preventive and control 
measures.  G/SPS/W/311/Add.1/Rev.1  
 
- 10 - 
 
  1.58.   Improvement of processes has posed a significant challenge for national veterinary services 
because the necessary information is dispersed in a wide range of sour ces and the recommendations 
issued by international agencies only consider a minimum of information.  
1.59.   For plants : Internal procedures for declaring and maintaining the status of disease -free or 
pest-free zones in Mexico are the Official Mexican Standards, w hich are listed below : 
1. Mexican Official Standard NOM -069-FITO-1995 on the establishment and recognition of 
pest-free areas ; 
2. Mexican Official Standard NOM -023-FITO-1995 establishing the National Campaign Against 
Fruit Flies.  
1.60.   These procedures are thus in lin e with International Standards for Phytosanitary Measures 
(ISPM):  
1. ISPM 26: Establishment of pest -free areas for fruit flies ( Tephritidae ); 
2. ISPM 4: Requirements for the establishment of pest -free areas.  
1.61.   Some challenges faced in maintaining these zones are the costs involved and legal oversight.  
What kind of Committee activities and documents are most useful to you in your domestic 
consultations on implementation of Article 6?  
1.62.   For animals : Workshops, courses, debates and directives or recommendations on 
implementation. Regionalization strategies led by other countries, as well as review and update of 
information generated by each Member regarding implementation of Article 6.  
1.63.   For plants : Reference to document G/SPS/48, Guidelines to Further the Practical 
Implementation of Article 6 of the Agreement on the Application of Sanitary and Phytosanitary 
Measures.  
Have you used the Committee's Guidelines on Regionalization (G/SPS/48) in your efforts 
to seek recognition by another Member of your domestic control an d enforcement systems 
for establishing and maintaining pest - or disease -free status? Are there areas of the 
Guidelines that could be improved?  
1.64.   For animals : They have been used both for obtaining recognition and for conferring it.  
1.65.   Veterinary services need t ime to respond and produce the file conferring recognition or 
formulating comments on the same. During this response time the authorities entrusted with 
handling the request need to evaluate the documents submitted.  
How do you use IPPC/OIE official pest - or disease -free country or zone status in 
implementing Article 6? In your efforts to seek recognition by another Member or 
Member(s), have you found that OIE or IPPC standards are interpreted and applied 
consistently? Are there areas where additional clarif ication in the international standards 
or guidelines would be beneficial?  
1.66.   For animals : It is used as part and parcel of the technical evaluation procedure for the 
recognition of animal disease -free and pest -free areas.  
1.67.   Implementation has been in conformity  with the general principles established by the OIE. 
More technical and scientific information (including sources) on implementation is needed to make 
proper use of regionalization.  
1.68.   For plants : In practice , few countries request recognition of pes t-free ar eas but when they 
do, the criteria used to analyze  the information and grant recognition where necessary are 
established in ISPM 4, ISPM 26 and ISPM 29.  G/SPS/W/311/Add.1/Rev.1  
 
- 11 - 
 
  1.69.   It is worth mentioning that the fact of recognizing a pest for the recognition of a pest -free 
area does  not necessarily imply establishing phytosanitary measures for imports since in addition, a 
pest risk analysis must be carried out.  
1.8  Chinese Taipei  
What are your domestic procedures for establishing and maintaining pest - or disease -free 
status? What challenges have you encountered in implementing such procedures?  
The Separate Customs Territory of Taiwan, Penghu, Kinmen and Matsu set up procedures to establish 
and maintain disease or pest -free area s in accordance with "Statute for Prevention and Contro l of 
Infectious Animal Disease " and "Plant Protection and Quarantine Act ". Relevant implementing 
regulations are established to prevent and control the occurrence, transmission or spread of animal 
and plant diseases and pests.  
1. To control domestic diseases  and pests:  
1) When establishing each implementing regulation, the competent authority invites 
stakeholders from relevant authorities, industries, academia and research institutes to 
take part in discussions , as well as collecting views from industrial groups , farmers, 
private companies and official inspectors to seek and achieve consent . 
2) To draft measures to monitor and control animal and plant diseases and pests based on 
OIE and IPPC standards , and to establish implementing regulation in order to enforce 
laws with penalties to violators.  
3) To continue collecting views from stakeholders and to adjust or amend pertinent 
measures in order to establish or maintain disease or pest -free status.  
2. Quarantine for importing animals, plants and their products:  
1) To prevent t he introduction of exotic animal and plant diseases and pests, the competent 
authority has established procedures of inspection and quarantine requirements for 
importing animals, plants and their products, as well as the designated fields to conduct 
animal  and plant quarantine.  
2) To consult with exporting country to proceed with desk review for risk assessment and 
to conduct on -site audit in order to recognize the animal and plant disease or pest -free 
status of exporting country and to make sure its SPS measures achieve our level of 
protection.  
3. Challenges in implementing the above -mentioned procedures : 
1) As for the prevention and control of animal and plant diseases, because lands for farming 
and husbandry are limited , and the lands are utilized extensively, these situations 
increase the difficulty of disease prevention and control.  
2) As for import quarantine, because the major part of agri -food consumption is imported 
from other countries, we need to prevent exotic disea ses or pests  being  introduc ed into 
our territory along with trade. Therefore, we have to strengthen import inspection and 
review capacity in order to maintain our disease or pest -free status.  
What kind of Committee activities and documents are most useful to you in your domestic 
consultations on implementation of Article 6?  
1.70.   It is helpful that Members share their experiences in establishing and maintaining disease -free 
areas in the thematic meeting s or workshop s held by the SPS Committee. Besides, the Commi ttee 
should encourage Members and regional organization s to apply for holding regional workshops in 
order to resolve the problem about disease transmission and disease -free area establishment in the 
region.  G/SPS/W/311/Add.1/Rev.1  
 
- 12 - 
 
  Have you used the Committee's Guidelines on Regio nalization (G/SPS/48) in your efforts 
to seek recognition by another Member of your domestic control and enforcement systems 
for establishing and maintaining pest - or disease -free status? Are there areas of the 
Guidelines that could be improved?  
1.71.   The Decisi on of guidelines to further the practical implementation of Article 6 approved by 
SPS Committee is valuable as a reference. The Separate Customs Territory of Taiwan, Penghu, 
Kinmen and Matsu has set up relevant review and recognition procedures based on re levant 
international standards, guidance and recommendations, and the recommendations of the Decision.  
How do you use IPPC/OIE official pest - or disease -free country or zone status in 
implementing Article 6? In your efforts to seek recognition by another M ember or 
Member(s), have you found that OIE or IPPC standards are interpreted and applied 
consistently? Are there areas where additional clarification in the international standards 
or guidelines would be beneficial?  
1.72.   We establish the recognition of disease  and pest -free area review procedure based on the OIE 
Terrestrial Animal Health Code and IPPC standards, mainly with ISPM 4 and ISPM 26. The exporting 
country must submit relevant technical information for us to review the case.  
1.73.   Besides, as for the phytosa nitary recognition of pest -free area s, we recommend that IPPC 
should establish more detailed guidelines in this field for WTO Member s’ reference.  
1.9  Ukraine  
What are your domestic procedures for establishing and maintaining pest - or disease -free 
status? What  challenges have you encountered in implementing such procedures?  
Phytosanitary information  
1.74.   The main international documents describing the procedures for the establishment of 
pest-free areas, production places and sites by which  Ukraine  is guided are:  
▪ WTO SPS Agreement;  
▪ ISPM No. 4 Requirements for the establishment of pest free areas;  
▪ ISPM No. 10 Requirements for the establishment of pest free places of production and pest 
free production sites.  
1.75.   Phytosanitary requirements of norms for objects of regulatio n (which will be exported to 
partner countries) concerning areas, production places and (or) sites free from definite pest - exports 
of such objects will be made exclusively from production places or production sites established in 
accordance with Article 31 of the Law of Ukraine "On Plant Quarantine" and the Procedure for the 
official establishment and/or maintenance of the status of a place of production or production site 
free of regulated pests, deprivation of such status, its renewal, and other conditi ons for the official 
establishment of the place of production or production site, approved by the order of the Ministry of 
Agrarian Policy and Food of Ukraine dated 7 August 2012 No. 487 . 
Problems  
▪ Low awareness of agricultural producers about the procedures for the establishment of 
pest- free areas, production places and sites ; 
▪ Setting the boundaries of buffer areas.  
Veterinary information  
1.76.   The Law of Ukraine "On Veterinary Medicine" define s in Article 22 , development, introduction 
and approval of v eterinary and sanitary measures. All veterinary and sanitary measures are based 
on international standards, guidelines and recommendations of relevant international organizations.  G/SPS/W/311/Add.1/Rev.1  
 
- 13 - 
 
  1.77.   In order to control animal diseases, the State Service of Ukraine on Food Sa fety and Consumer 
Protection (SSUFSCP) and scientific institutions under the control of the SSUFSCP annually develop 
the Plan of anti -epizootic measures for the prevention main infectious parasitic animal diseases in 
Ukraine ; the State plan of monitoring o f infectious diseases on the territory of Ukraine is approved , 
and Procedure for carrying out monitoring researches on infectious diseases.  
What kind of Committee activities and documents are most useful to you in your domestic 
consultations on implementat ion of Article 6?  
1.78.   Article 6  of the  WTO SPS Agreement is used for the national (intra -state) harmonization of 
normative legal acts, for vertical as well as horizontal legislation. For example,  the Order "On 
approving requirements for importing (sending) int o the customs territory of Ukraine of live animals, 
their reproductive material, food products of animal origin, feed, hay, straw, as well as by -products 
of animal origin and products of their processing" from 16  November 2018 #553, 
https://zakon.rada.gov.ua/laws/show/z0346 -19. 
Have you used the Committee's Guidelines on Regionalization (G/SPS/48) in your efforts 
to seek recognition by another Member of your domestic control and enforcement systems 
for establishing and maintaining pest - or disease -free status?  Are there areas of the 
Guidelines that could be improved?  
Phytosanitary information  
1.79.   Not used. However, the Competent Authority in Ukraine (SSUFSCP) is guided by ISPM No. 4 
Requirements for the establishment of pest free areas and ISPM No. 10 Requirements for the 
establishme nt of pest free places of production and pest free production sites.  
Veterinary information  
1.80.   Not used. However, in drafting regulations that are considered regionalization standards 
Health Code OIE Terrestrial Animal chapters 4.3 and 4.4 of the establishmen t in Ukraine 
compartmentalization mechanism.  
How do you use IPPC/OIE official pest - or disease -free country or zone status in 
implementing Article 6? In your efforts to seek recognition by another Member or 
Member(s), have you found that OIE or IPPC standa rds are interpreted and applied 
consistently? Are there areas where additional clarification in the international standards 
or guidelines would be beneficial?  
1.81.   Ukraine based its SPS measures on the standards, directives and recommendations of the 
Codex Alim entarius Commission, the World Organisation for Animal Health (OIE) and the 
International Plant Protection Convention (IPPC) in accordance with the requirements of the 
WTO SPS Agreement.  
1.82.   Some countries do not always take into account IPPC / OIE status  of pest and animal disease  
freedom  for a country or an area. The y need to comply with the laws of the exporting country.  
Phytosanitary information  
1.83.   Letters to the Members are sent with the request to recognize the territory of Ukraine as a 
free area from the quarantine organisms included in the list A1 of the List of regulated pests 
(quarantine organisms) approved by the Order of the Ministry of Agrarian Policy of Ukraine, 
29 November 2006 No. 716 "On Approval the List of Regulated Pests".  
1.84.   In order to implemen t the phytosanitary requirements, it is proposed that agricultural 
producers and exporters establish sites and places of production free of pests, if such an action is 
required by the country of import.  
1.85.   Application form and procedure approved by order of t he Ministry of Agrarian Policy and Food 
of Ukraine, 8  September  2012 № 487, the fee for the inspection of agricultural crops to detect 
quarantine organisms to provide and/or confirm the status of the place of production or production G/SPS/W/311/Add.1/Rev.1  
 
- 14 - 
 
  sites at the request o f the person who produces the regulated objects by the Law of Ukraine "On 
Plant Quarantine" approved by the Resolution of the Cabinet of Ministers of Ukraine, 
28 December  2011 No. 1348. In order to establish the status of the place of production or product ion 
site free from pest, the business operator is provided to the territorial authority of the SSUFSCP.  
Veterinary information  
1.86.   Letters to the Members (Competent Authorities) are sent to the information on outbreaks of 
infectious animal diseases for their e limination and notification through international organizations 
(OIE, WTO) and bilaterally.  
Other comments  
1.87.   Ukraine submits the following question to the OIE : 
▪ 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?  
2  QUESTIONS FOR MEMBER S AND IPPC AND OIE R EPRESENTATIVES  
2.1  Brazil  
Are there ways for the SPS Committee to collaborate more effectively with IPP C and OIE 
to strengthen implementation of international standards on regionalization and Article 6?  
2.1.   The SPS Committee should seek greater commitment from Member s towards recognition of 
health statuses established by the OIE or in accordance with the stand ards of IPPC without undue 
delay or, in case of non -recognition of the health status of a country or zone, justify ing to the 
exporting party the scientific reasons for non -recognition.  
How have Members without elaborate SPS programmes relied on OIE or IPPC  work to 
facilitate safe importation of needed food products?  
2.2.   In the case of animal health, the OIE standards are built on a broad process with free 
participation of the member countries and are usually based on a sound scientific basis and can 
therefore be considered reliable for the safe trade of food.  
2.2  European Union  
Are there ways for the SPS Committee to collaborate more effectively with IPPC and OIE 
to strengthen implementation of international standards on regionalization and Article 6?  
2.3.  In 2018, the World Assembly of OIE  Delegates adopted a resolution recommending the 
establishment of an Observatory on the implementation of OIE Standards by its member countries. 
Monitoring, identifying and analyzing  difficulties faced by its member countries enables the OIE to 
ensure a more effective implementation of its standards, including regionalization . The European 
Union strongly supports this initiative and hopes that  it will facilitate the good understanding and 
application of the regionalization  principles worldwide.  
2.4.  The E uropean Union also see s the benefits of similar initiatives to be carried out by IPPC. The 
European Union welcomes the activities of the IPPC regarding the development of a guide on 
pest-free areas.   
2.5.  In the opinion of the E uropea n Union, it is very important that OIE and IPPC continue to share 
regularly the state of play of their work on regionalization  with the SPS Committee.  
2.3  Hong Kong, China  
Are there ways for the SPS Committee to collaborate more effectively with IPPC and OIE 
to strengthen implementation of international standards on regionalization and Article 6?  G/SPS/W/311/Add.1/Rev.1  
 
- 15 - 
 
  2.6.  No comment.  
How have Members without elaborate SPS programmes relied on OIE or IPPC work to 
facilitate safe importation of needed food products?  
2.7.  The Centre for Food S afety (CFS) is the food safety authority under the Food and Environmental 
Hygiene Department.  It makes reference to the OIE recommendations for importation of meat for 
consumption when negotiating import protocols with a potential exporting country.  CFS al so adopts 
the concept of zoning and compartmentalization as recommended by the OIE to ensure the safety 
of imported food.  
2.4  Japan  
Are there ways for the SPS Committee to collaborate more effectively with IPPC and OIE 
to strengthen implementation of international standards on regionalization and Article 6?  
2.8.  It would be beneficial for all the Members to share the examples of questions of importing 
Members which the exporting Members could not answer or the data the exporting Members did not 
have, in the  aim of identifying the type of capacity building needed by Members, especially 
developing countries, for implementing pest or disease -free areas. 
How have Members without elaborate SPS programmes relied on OIE or IPPC work to 
facilitate safe importation o f needed food products?  
2.9.  Not applicable . 
2.5  Mexico  
Are there ways for the SPS Committee to collaborate more effectively with IPPC and OIE 
to strengthen implementation of international standards on regionalization and Article 6?  
2.10.   For animals : Yes, by encouraging  the participation of persons with direct responsibility (in 
each country) for the understanding and implementation of regionalization in ISPM and OIE 
meetings. This would enable them to draft technical documents that contain real case studies and 
tried an d tested alternative solutions, thus facilitating the understanding of each Member and 
building their capacity to identify, resolve and document problems and share success stories, which 
can then be incorporated into international standards.  
2.11.   For plants : Through IPPC meetings in which they participate in an individual capacity. At 
these forums they can express the concerns of the Committee and of WTO Members.  
How have Members without elaborate SPS programmes relied on OIE or IPPC work to 
facilitate safe impo rtation of needed food products?  
2.12.   For animals : The OIE's analysis is based on available scientific evidence.  
2.13.   For plants : In the case of Mexico, when phytosanitary requirements are negotiated for the 
export of produce to countries that do not have an SPS sys tem or programme, the ISPM is the most 
important reference for facilitating formalities. This is where the importance of the IPPC's standard 
setting work and its capacity to remain updated come into play.  
2.6  Chinese Taipei  
Are there ways for the SPS Committee  to collaborate more effectively with IPPC and OIE 
to strengthen implementation of international standards on regionalization and Article 6?  
 
2.14.   No comment.  G/SPS/W/311/Add.1/Rev.1  
 
- 16 - 
 
  How have Members without elaborate SPS programmes relied on OIE or IPPC work to 
facilitate safe import ation of needed food products?  
2.15.   No comment.  
__________