REGIONALIZATIONREGIONALIZATIONpractical considerationspractical considerations

Ing Agr. Diana Maria GuillenIng Agr. Diana Maria GuillenNational Director for Plant Health National Director for Plant Health

SENASASENASAArgentinaArgentina

February 2006February 2006

Basic AssumptionsBasic Assumptions

By adopting the principle of regionalization, By adopting the principle of regionalization, the SPS Agreement aimed at two goals: the SPS Agreement aimed at two goals:

i.i. Urging Members to improve their sanitary Urging Members to improve their sanitary and phytosanitary condition and phytosanitary condition

ii.ii. Facilitating access of agri-food products Facilitating access of agri-food products to foreign markets.to foreign markets.

It is our opinion that these two goals must be It is our opinion that these two goals must be considered provided the issue is considered provided the issue is

discussed when adopting international discussed when adopting international regulations or in multilateral and bilateral regulations or in multilateral and bilateral

negotiations. negotiations.

Basic AssumptionsBasic Assumptions

It has been noted that:It has been noted that: A significant number of Members, in A significant number of Members, in

particular developing ones,have reported particular developing ones,have reported unnecessary and unjustified delays in unnecessary and unjustified delays in proceedings for regionalization proceedings for regionalization recognition.recognition.

Such delays undermine one of the Such delays undermine one of the Agreement goals, to the detriment of and Agreement goals, to the detriment of and causing disbelief among Peers.causing disbelief among Peers.

In many occasions delays are due to legal, In many occasions delays are due to legal, administrative or procedural matters. administrative or procedural matters.

Basic AssumptionsBasic Assumptions

Experience gathered over 10 years of work in Experience gathered over 10 years of work in the plant protection area was shared in the plant protection area was shared in

Notice distributed under G/SPS/GEN/606.Notice distributed under G/SPS/GEN/606.

It should be noted that no consideration has been It should be noted that no consideration has been given to given to unjustified delay,unjustified delay, as the strategy used as the strategy used by some countries unwilling to open their by some countries unwilling to open their markets.markets.

An attempt has been made to systematize An attempt has been made to systematize difficulties encountered during recognition of difficulties encountered during recognition of areas with sanitary and phytosanitary differences.areas with sanitary and phytosanitary differences.

Possible causes for delay incurred by countries Possible causes for delay incurred by countries when responding to a regionalization request of a when responding to a regionalization request of a third country have been evaluated.third country have been evaluated.

What does What does regionalization regionalization involve for an exporting involve for an exporting

Member?Member?National identification and National identification and recorecognition of a region gnition of a region with different with different sanitarsanitaryy o or phyr phytosanitartosanitary condition y condition

is a process thatis a process that:: Takes years of workTakes years of work.. Requires large human resources and big financial Requires large human resources and big financial

investmentsinvestments.. Demands application of new annual resources to Demands application of new annual resources to

maintain the status, surveillance and contingenciesmaintain the status, surveillance and contingencies..

Such investment – of time, manpower and money – Such investment – of time, manpower and money – is worth for a society, which is always affected, is worth for a society, which is always affected,

when there is a chance of entering markets until when there is a chance of entering markets until then closed or presenting complex or even then closed or presenting complex or even

expensive application restrictionsexpensive application restrictions..

Problems IdentifiedProblems Identified

They can be break down as follows: They can be break down as follows: Regarding domestic order of Regarding domestic order of

importing country.importing country. Regarding importer/exporter bilateral Regarding importer/exporter bilateral

relationship.relationship. Regarding reference international Regarding reference international

regulations.regulations.

Regarding Domestic Order of Regarding Domestic Order of Importing CountryImporting Country

Lack of domestic legislation compatible with Lack of domestic legislation compatible with new International Agreements (acts passed new International Agreements (acts passed before 1995).before 1995).

Confused and non-explicit definitions of Confused and non-explicit definitions of Suitable Protection Levels, leading to the Suitable Protection Levels, leading to the application of the risk “0” concept. application of the risk “0” concept.

Lack of domestic legislation providing for Lack of domestic legislation providing for proceedings to determine and/or recognise proceedings to determine and/or recognise regionalization in a practical manner (free regionalization in a practical manner (free areas, low prevalence areas, etc)areas, low prevalence areas, etc)

Lack of regulations and clear definitions at Lack of regulations and clear definitions at decision-making level promote doubt and decision-making level promote doubt and confusion in technicians, who delay confusion in technicians, who delay proceedings. proceedings.

Regarding importer/exporter Regarding importer/exporter bilateral relationshipbilateral relationship

Absence of a pest in the importing country may cause: Absence of a pest in the importing country may cause: Lack of knowledge of pest biology, hosts,weather changes Lack of knowledge of pest biology, hosts,weather changes

affecting it, etc; resulting in uncertainty of surveillance and affecting it, etc; resulting in uncertainty of surveillance and monitoring systems, their sensitivity, taxonomic monitoring systems, their sensitivity, taxonomic identifications, of lab analyses and their sensitivity and identifications, of lab analyses and their sensitivity and depriving the actual possibility of identifying areas with depriving the actual possibility of identifying areas with different status, etc. different status, etc.

Technicians lacking specific training on the pest and the Technicians lacking specific training on the pest and the possibility of identifying differentiated areas. possibility of identifying differentiated areas.

Other limitations may derive from: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 Long periods lacking communication, with reiteration of

information requests, etc.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 Pressure exerted on regulatory bodies, whether by the

private sector or by judicial authorities.private sector or by judicial authorities.

Regarding reference Regarding reference international regulationsinternational regulations

World Organization for Animal HealthWorld 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 Scarce Members participation in evaluation meetings

may result in lack of knowledge of systems applied may result in lack of knowledge of systems applied by country requesting regionalization. It is decided by country requesting regionalization. It is decided not to rely on it. not to rely on it.

Lack of short proceedings allowing immediate status Lack of short proceedings allowing immediate status recognition following OIE recognition.recognition following OIE recognition.

Members that, in spite of OIE recognition, go through Members that, in spite of OIE recognition, go through all steps of recognition procedures.all steps of recognition procedures.

Not recognised status Not recognised status Members decide not to deal with the issue until OIE Members decide not to deal with the issue until OIE

does so.does so. Negotiations are delayed in fear of recognition.Negotiations are delayed in fear of recognition.

Regarding reference Regarding reference international regulations.international regulations.

INTERNATIONAL PLANT PROTECTION INTERNATIONAL PLANT PROTECTION CONVENTION CONVENTION

In case of lack of specific standards, In case of lack of specific standards, horizontal-general standards are applied. horizontal-general standards are applied. Stages identified in the Annex are carried Stages identified in the Annex are carried out. out.

The possibility of developing an OIE like The possibility of developing an OIE like system is under discussion; however, system is under discussion; however, several Members believe that given the several Members believe that given the characteristics and number of pests to be characteristics and number of pests to be regulated the system might hinder trade – regulated the system might hinder trade – instead of fostering it.instead of fostering it.

Actions and critical Actions and critical point Flow Chartpoint Flow Chart

Possible steps Critical points

Regionalization request Presenting information

Bilateral AgreementTime 0

Documental evaluationRequest of additional

information

1°critical point of delay Pest is not known.

There is not enough staff (¿months?, ¿years?)

Documental evaluation 2° critical point of delay Ignorance of steps to be followed when assessing

documentation

“In situ” evaluation 3° critical point of delay Sending a mission. It may take years of request or

discussion.

Audit report Request of additional

informationRequest of amendments

4° critical point of delay Possible situation if pest is not known or there is no specific international

regulation.

Additional audit (possibly)

¿5° critical point of delay ?

Amendment of domestic ruleDrafting

¿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?

Final considerations Final considerations

Difficulties identified above are not Difficulties identified above are not exhaustive and a series of measures exhaustive and a series of measures should be adopted to overcome them, should be adopted to overcome them, which includes: which includes: Preparing guidelines within the framework of the Preparing guidelines within the framework of the

WTO/SPS Committee, to have clear, foreseeable and WTO/SPS Committee, to have clear, foreseeable and precise rules regarding recognition proceedings.precise rules regarding recognition proceedings.

Adopting said guidelines in domestic legislation.Adopting said guidelines in domestic legislation. Executing co-operation agreements among Members, in Executing co-operation agreements among Members, in

particular regarding bilateral negotiation of particular regarding bilateral negotiation of regionalization whenever regulatory arrangements, regionalization whenever regulatory arrangements, technical training and pest information are required.technical training and pest information are required.

Let’s remind that Let’s remind that although this topic is although this topic is

extremely significant to extremely significant to all countries, it is all countries, it is

particularly important to particularly important to developing countries, and developing countries, and

goals of the SPS goals of the SPS Agreement will not be Agreement will not be

achieved unless we achieved unless we provide ourselves with provide ourselves with effectiveeffective instruments to instruments to open markets within a open markets within a

reasonable time and with reasonable time and with sanitary safegurads.sanitary safegurads.

Thank you Thank you