1. REGIONALIZATION practical considerations Ing Agr. Diana Maria Guillen National Director for Plant Health SENASAArgentina February 2006

2. Basic Assumptions By adopting the principle of regionalization, the SPS Agreement aimed at two goals: i. Urging Members to improve their sanitary and phytosanitary condition ii. Facilitating access of agri-food products to foreign markets. It is our opinion that these two goals must be considered provided the issue is discussed when adopting international regulations or in multilateral and bilateral negotiations.

3. Basic Assumptions It has been noted that: A significant number of Members, in particular developing ones,have reported unnecessary and unjustified delays in proceedings for regionalization recognition. A significant number of Members, in particular developing ones,have reported unnecessary and unjustified delays in proceedings for regionalization recognition. Such delays undermine one of the Agreement goals, to the detriment of and causing disbelief among Peers. Such delays undermine one of the Agreement goals, to the detriment of and causing disbelief among Peers. In many occasions delays are due to legal, administrative or procedural matters. In many occasions delays are due to legal, administrative or procedural matters.

4. Basic Assumptions Experience gathered over 10 years of work in the plant protection area was shared in Notice distributed under G/SPS/GEN/606. It should be noted that no consideration has been given to unjustified delay, as the strategy used by some countries unwilling to open their markets. It should be noted that no consideration has been given to unjustified delay, as the strategy used by some countries unwilling to open their markets. An attempt has been made to systematize difficulties encountered during recognition of areas with sanitary and phytosanitary differences. An attempt has been made to systematize difficulties encountered during recognition of areas with sanitary and phytosanitary differences. Possible causes for delay incurred by countries when responding to a regionalization request of a third country have been evaluated. Possible causes for delay incurred by countries when responding to a regionalization request of a third country have been evaluated.

5. What does regionalization involve for an exporting Member? National identification and recognition of a region with different sanitary or phytosanitary condition is a process that: Takes years of work. Takes years of work. Requires large human resources and big financial investments. Requires large human resources and big financial investments. Demands application of new annual resources to maintain the status, surveillance and contingencies. Demands application of new annual resources to maintain the status, surveillance and contingencies. Such investment – of time, manpower and money – is worth for a society, which is always affected, when there is a chance of entering markets until then closed or presenting complex or even expensive application restrictions. Such investment – of time, manpower and money – is worth for a society, which is always affected, when there is a chance of entering markets until then closed or presenting complex or even expensive application restrictions.

6. Problems Identified They can be break down as follows: Regarding domestic order of importing country. Regarding domestic order of importing country. Regarding importer/exporter bilateral relationship. Regarding importer/exporter bilateral relationship. Regarding reference international regulations. Regarding reference international regulations.

7. Regarding Domestic Order of Importing Country Lack of domestic legislation compatible with new International Agreements (acts passed before 1995). Lack of domestic legislation compatible with new International Agreements (acts passed before 1995). Confused and non-explicit definitions of Suitable Protection Levels, leading to the application of the risk “0” concept. Confused and non-explicit definitions of Suitable Protection Levels, leading to the application of the risk “0” concept. Lack of domestic legislation providing for proceedings to determine and/or recognise regionalization in a practical manner (free areas, low prevalence areas, etc) Lack of domestic legislation providing for proceedings to determine and/or recognise regionalization in a practical manner (free areas, low prevalence areas, etc) Lack of regulations and clear definitions at decision- making level promote doubt and confusion in technicians, who delay proceedings. Lack of regulations and clear definitions at decision- making level promote doubt and confusion in technicians, who delay proceedings.

8. Regarding importer/exporter bilateral relationship Absence of a pest in the importing country may cause: Lack of knowledge of pest biology, hosts,weather changes affecting it, etc; resulting in uncertainty of surveillance and monitoring systems, their sensitivity, taxonomic identifications, of lab analyses and their sensitivity and depriving the actual possibility of identifying areas with different status, etc. Lack of knowledge of pest biology, hosts,weather changes affecting it, etc; resulting in uncertainty of surveillance and monitoring systems, their sensitivity, taxonomic identifications, of lab analyses and their sensitivity and depriving the actual possibility of identifying areas with different status, etc. Technicians lacking specific training on the pest and the possibility of identifying differentiated areas. Technicians lacking specific training on the pest and the possibility of identifying differentiated areas. Other limitations may derive from: Large number of applications for area recognition. Large number of applications for area recognition. Long periods lacking communication, with reiteration of information requests, etc. Long periods lacking communication, with reiteration of information requests, etc. Lack of knowledge and reliability among Services. Lack of knowledge and reliability among Services. Pressure exerted on regulatory bodies, whether by the private sector or by judicial authorities. Pressure exerted on regulatory bodies, whether by the private sector or by judicial authorities.

9. Regarding reference international regulations World Organization for Animal Health If it is a disease dealt with at OIE level If it is a disease dealt with at OIE level Recognised status. Recognised status. Scarce Members participation in evaluation meetings may result in lack of knowledge of systems applied by country requesting regionalization. It is decided not to rely on it. Scarce Members participation in evaluation meetings may result in lack of knowledge of systems applied by country requesting regionalization. It is decided not to rely on it. Lack of short proceedings allowing immediate status recognition following OIE recognition. Lack of short proceedings allowing immediate status recognition following OIE recognition. Members that, in spite of OIE recognition, go through all steps of recognition procedures. Members that, in spite of OIE recognition, go through all steps of recognition procedures. Not recognised status Not recognised status Members decide not to deal with the issue until OIE does so. Members decide not to deal with the issue until OIE does so. Negotiations are delayed in fear of recognition. Negotiations are delayed in fear of recognition.

10. Regarding reference international regulations. INTERNATIONAL PLANT PROTECTION CONVENTION In case of lack of specific standards, horizontal-general standards are applied. Stages identified in the Annex are carried out. The possibility of developing an OIE like system is under discussion; however, several Members believe that given the characteristics and number of pests to be regulated the system might hinder trade – instead of fostering it.

11. Actions and critical point Flow Chart

12. Possible stepsCritical points Regionalization request Presenting information Bilateral Agreement Time 0 Documental evaluation Request of additional information 1°critical point of delay Pest is not known. There is not enough staff (¿months?, ¿years?) Documental evaluation2° critical point of delay Ignorance of steps to be followed when assessing documentation “In situ” evaluation3° critical point of delay Sending a mission. It may take years of request or discussion. Audit report Request of additional information Request of amendments 4° critical point of delay Possible situation if pest is not known or there is no specific international regulation.

13. Additional audit (possibly) ¿5° critical point of delay ? Amendment of domestic rule Drafting ¿Public Comment? Comment results Preparation of final rule ¿Passing? 6° critical point of delay ° Subsequent authorisations 7° critical point of delay It is impossible to determine administrative time of these stages; sometimes it takes at least 1 year. Registration of plants, exporters,etc. 8° critical point of delay : they may be administrative and shared with other administration units Inspection visit for approval and licencing to access the market 9° critical point of delay Beginning of a different, frustrating process, end of which is uncertain. MARKET OPENING 10° critical point of delay Uncertain ending after 5, 8, 10, 15 years?

14. Final considerations Difficulties identified above are not exhaustive and a series of measures should be adopted to overcome them, which includes: Difficulties identified above are not exhaustive and a series of measures should be adopted to overcome them, which includes: Preparing guidelines within the framework of the WTO/SPS Committee, to have clear, foreseeable and precise rules regarding recognition proceedings. Preparing guidelines within the framework of the WTO/SPS Committee, to have clear, foreseeable and precise rules regarding recognition proceedings. Adopting said guidelines in domestic legislation. Adopting said guidelines in domestic legislation. Executing co-operation agreements among Members, in particular regarding bilateral negotiation of regionalization whenever regulatory arrangements, technical training and pest information are required. Executing co-operation agreements among Members, in particular regarding bilateral negotiation of regionalization whenever regulatory arrangements, technical training and pest information are required.

15. Let’s remind that although this topic is extremely significant to all countries, it is particularly important to developing countries, and goals of the SPS Agreement will not be achieved unless we provide ourselves with effective instruments to open markets within a reasonable time and with sanitary safegurads.

16. Thank you