trade in animal products opportunities and … · against rabies . bse-related restrictions . world...

World Organisation for Animal Health · Protecting animals, Preserving our future | 1

TRADE IN ANIMAL PRODUCTS OPPORTUNITIES AND CHALLENGES - THE PERSPECTIVE OF OIE Control of Animal Diseases-Regionalisation International Seminar Bangkok, Thailand, 5 June 2018


Framework for Safe International Trade

Zoning and Compartimentalisation

Free status – official recognition vs self declaration

Contents

Implementation of OIE Standards


Part 1

Framework for Safe International Trade


WTO SPS Agreement – key points

legal framework for international trade

legally binding for WTO Members

includes obligations for importing countries AND exporting

countries

Recognises OIE as international standard setting

organisation for animal health and zoonoses

If you apply OIE standards you are complying with WTO

obligations


Recognizing the right to protect human, animal, plant life or health

Avoiding unnecessary barriers to trade

What is the objective of the SPS Agreement?


“Members have the right to take sanitary and phytosanitary measures necessary for the protection of human, animal or plant life or health, provided that such measures are not inconsistent with the provisions of this Agreement”

SPS Agreement - Coverage Article 2.1


SPS Measures - Examples Annex A

A measure taken to protect:

Animals from diseases

e.g. measures to prevent

introduction of Taura syndrome

e.g. measures to prevent

introduction of FMD


SPS Measures - Examples Annex A

Human life animal-carried diseases from

A measure taken to protect:

requirement that susceptible animals

be vaccinated against rabies

BSE-related restrictions

http://upload.wikimedia.org/wikipedia/commons/9/95/Aphis.usda.gov_BSE_3.jpg


Members shall ensure that any SPS measure is:

Scientific Justification Article 2.2

applied only to the extent necessary to protect human, animal or plant life or health

based on scientific principles

not maintained without sufficient scientific evidence

except as provided for in Article 5.7

Presenter

Presentation Notes

Article 5.7 In the absence of sufficient scientific evidence, Members may adopt provisional SPS measures based on available information.


Scientific Justification Article 3.3

A country’s import health measures must be based on an: International standards(OIE);

OR

Import Risk Analysis:

- in the absence of a relevant standard; or - when a Member chooses to adopt a higher standard

of protection than the international standard provides.

Risk analysis

Presenter

Presentation Notes

Article 5.7 In the absence of sufficient scientific evidence, Members may adopt provisional SPS measures based on available information.


No unjustifiable discrimination between Members with similar conditions i.e. no import requirements for diseases present in the importing country unless subject to any official control programme

Non-discrimination Article 2.3


Disease-free areas Article 6

Concept of disease-free country, zone and compartment is recognised in the SPS Agreement (Article 6)

Members must recognize concept of disease-free areas

“To gain recognition of a disease-free area, an exporting Member has to provide the necessary proof (Article 6.3)”


Disease-free areas Article 6

Members shall ensure SPS measures (for disease-free areas) take into account:

prevalence of disease existence of eradication or control programmes guidelines developed by “sisters” (e.g. OIE official

recognition of disease status)

SPS Guidelines on Regionalization (G/SPS/48)

OIE standards and guidance is provided in disease-specific chapters, Ch 1.4, 4.3, 4.4. etc.


Equivalence Article 4.1

Members shall

accept SPS measures of other Members as equivalent

If the exporting Member objectively demonstrates that its measures achieve the

ALOP of the importing country

Committee Guidelines on Equivalence

(G/SPS/19/Rev.2)

http://www.google.ch/url?sa=i&rct=j&q=&esrc=s&frm=1&source=images&cd=&cad=rja&uact=8&docid=FoG-xINORs9sxM&tbnid=yhjGHuxNPs_fhM:&ved=0CAUQjRw&url=http://kbf123.com/shopisticated-uv-light-bulb/uv-light-bulb-water/&ei=Pi88U_qGJ8TNONrKgbgO&bvm=bv.63934634,d.ZWU&psig=AFQjCNFzGuFvA0nkYAh21v1cbLw_9cqqbQ&ust=1396539207276017


Chapter 5.3. OIE procedures relevant to the WTO SPS Agreement

Article 5.3.1. SPS Agreement in brief

Articles 5.3.2. to 5.3.6. General considerations on the judgement of

the equivalence of sanitary measures

Article 5.3.7. Sequence of steps to be taken in establishing

a zone/compartment and having it recognised for international trade purposes

Presenter

Presentation Notes

Also under the WTO SPS Agreement, the OIE is recognised as the international standard setting organisation for animal health and zoonoses What is an OIE standard? - A text that has been formally adopted by the OIE World Assembly of Delegates - A text that describes requirements and recommendations that should be used consistently to ensure the improvement of animal health, veterinary public health and animal welfare worldwide. Standards that are highly prescriptive do not get agreement from the World Assembly because they need to be workable all 180 MCs. They need to be flexible enough to adapt to each Member Countries’’ own situation. Standards are evolving. - Initially focused on pathogen approach, ie OIE listed diseases, ie have international importance and to ensure safe trade. Also broader issues, eg animal feed; biosecurity: started with poultry production; some in Salmonella in pigs and cattle; plans for new chapter on biosecurity. - Now developing standards to improve animal health and welfare and public health worldwide. With addressing horizontal issues, eg biosecurity. The Oie standard setting process is transparent responsive and democratic


Part 2

Zoning and Compartmentalisation


Zoning & Compartmentalisation o Procedures to define subpopulations of distinct health status

o For the purpose of disease control or international trade

o Establish and maintain a disease free status within a territory where disease eradication is not possible in a short time

Zoning Compartmentalisation

Applies to an animal subpopulation defined primarily

on a geographical basis (using natural, artificial or legal

boundaries)

Applies to an animal subpopulation defined primarily by management and husbandry practices related to biosecurity

In practice, spatial considerations and good management including biosecurity plans play important roles in the application of both concepts.

Presenter

Presentation Notes

Given the difficulty of establishing and maintaining a disease free status for an entire territory, especially for diseases the entry of which is difficult to control through measures at national boundaries, there may be benefits to a Member Country in establishing and maintaining a subpopulation with a distinct health status within its territory.


free zone

free zone

river

Zoning

Infected zone

Based on geographical boundaries


BREEDING FLOCK FEED

SUPPLY

GROWING FLOCK

SLAUGHTER HOUSE

GROWING FLOCK

Birds

Equipment

Equi

pmen

t

Feed

Compartmentalisation

Equipment

Feed

Based on management practices and biosecurity


Zone means a clearly defined part of a territory containing an animal subpopulation with a distinct health status with respect to a specific disease for which required surveillance, control and biosecurity measures have been applied for the purpose of international trade. Compartment means an animal subpopulation contained in one or more establishments under a common biosecurity management system with a distinct health status with respect to a specific disease or specific diseases for which required surveillance, control and biosecurity measures have been applied for the purpose of international trade.

Zoning & Compartmentalisation


Zoning: encourage the more efficient use of resources within certain parts of a country.

Compartmentalisation: allow the functional separation of a subpopulation from other domestic animals or wild animals through biosecurity measures, which a zone would not achieve.

Use of compartmentalisation, following a disease outbreak, may allow a Country to take advantage of epidemiological links among subpopulations or common practices relating to biosecurity, despite diverse geographical locations, to facilitate disease control or the continuation of trade.

Trading partners should establish parameters and gaining agreement on the necessary measures prior to outbreaks of disease



Biosecurity and surveillance are essential components of zoning and compartmentalisation

The arrangements should be developed through cooperation of industry and Veterinary Services.


Industry

•Application of biosecurity measures

•Documenting and recording movements of animals and personnel

•Quality assurance schemes

•Monitoring the efficacy of the measures

•Documenting corrective actions

•Conducting surveillance

•Rapid reporting and maintenance of records in a readily accessible form

Veterinary Services

•Provide movement certification,

•Carry out documented periodic inspections of facilities, biosecurity measures, records and surveillance procedures.

•Audit surveillance, reporting and laboratory diagnostic examinations.

http://www.oie.int/index.php?id=169&L=0&htmfile=glossaire.htm



The Veterinary Authority should document in detail the measures taken to ensure the identification of the subpopulation and the establishment and maintenance of its health status through a biosecurity plan.

The measures used to establish and maintain the distinct animal health status of a zone or compartment depend on the epidemiology of the disease, environmental factors, the health status of animals in adjacent areas, applicable biosecurity measures, and surveillance.

Relevant animals within the zone or compartment should be identified in such a way that their movements are traceable.

A zone or compartment should be made public through official channels.



Zone A protection zone may be established to preserve the health

status of animals in a free country or zone, from adjacent countries or zones of different animal health status.

Measures to prevent introduction of the pathogenic agent and to ensure early detection (movement control; surveillance; animal ID and traceability; vaccination; testing or vaccination of animals moved, specific procedures for sample handling, sending and testing; enhanced biosecurity, awareness campaigns)

A containment zone may be established for trade purposes in the event of limited outbreaks in a country or zone previously free of a disease. Measures applied to eradicate the disease.

The effective a containment zone establishment is no new cases in the containment zone within a minimum of two incubation periods from the last detected case.

Presenter

Presentation Notes

The application of these measures can be in the entire free zone or in a defined area within or outside the free zone. Containment zone – stamping-out policy or another effective control strategy to eradicate the disease




Compartment Biosecurity Plan

o The partnership between the relevant industry and the Veterinary Authority, and their respective responsibilities

o The operating procedures provide evidence that the surveillance conducted, the live animal identification and traceability system, and the management practices are adequate to meet the definition of the compartment

o Herd or flock production records, feed sources, surveillance results, birth and death records, visitor logbook, morbidity and mortality history, medications, vaccinations, documentation of training of relevant personnel and any other criteria necessary for evaluation of risk mitigation.

o The audit to ensure that the risks are regularly re-assessed and the measures adjusted accordingly





Part 3

Disease Free Status OIE Official Recognition

vs Self-declaration


R. Doisneau

How do I find out if the country I wish to trade with is free from a specific OIE listed disease

of concern to me?

Do they have OIE official

recognition of disease status?

What is their disease status

in WAHIS? present/absent/

not reported

Have they made

a self-declaration of

freedom


Disease-free recognition – SPS Agreement

“Any determination under Article 6 should consider the strength and credibility of the veterinary infrastructure of the exporting Member in accordance with the importing Member’s appropriate level of sanitary protection” “The veterinary authorities of the exporting Member should be able to demonstrate their ability to maintain freedom from specified diseases to encourage confidence on the part of the importing Member”

Article 6 &

RG/SPS/48 Guidelines


Disease-free recognition – SPS Agreement

TYPICAL STEPS IN THE RECOGNITION PROCESS Step A: Exporting Member requests information about procedures and/or

recognition Step B: Importing Member explains requirements Step C: Exporting Member provides documentation Step D: Importing Member evaluates the documentation and, if necessary,

requests additional information Step E: Exporting Member responds to feedback Step F: Importing Member evaluates any additional information and, if

required, seeks further clarifications Step G: Importing Member conducts on- site verification (if applicable) Step H: Exporting Member responds to inspection report Step I: Importing Member makes a determination

Article 6 &

RG/SPS/48 Guidelines


OIE OFFICIAL DISEASE STATUS RECOGNITION

Protect animal and human health in international trade

Facilitate trade

Guarantees to trading partners, • Veterinary Services meet baseline requirements

concerning disease control and trade activities;

• Long term perspective documented and updated evidence on the disease free situation.

Presenter

Presentation Notes

Objectives


OIE official recognition of disease status 19

94 • Requested by

the World Assembly

• Voluntary-based procedure

• Specific diseases

1995

Adoption of the procedure for FMD official recognition

1996

Adoption of the 1st list of Member Countries and zones free from FMD without vaccination

HISTORICAL


FMD Country/ Zone With/ without

vaccination

1996

Rinderpest

2000 Contagious bovine

pleuropneumonia

Country/ Zone

2003

BSE Country/ Zone

Negligible / Controlled risk

2004

African horse

sickness Country

2013 Peste de

petits ruminant

Country/ Zone

2014 Classical

swine fever Country/ Zone

2015

Diseases included in OIE official disease status recognition (at 2017)

Also OIE endorsement (by Resolution) of official control programmes for FMD, CBPP and PPR


Granting, suspension and recovery of official disease status

http://www.oie.int/en/animal-health-in-the-world/official-disease-status/official-recognition-policy-and-procedures/

Objective and Transparent Procedure; Standard Operating Procedure – describes all steps in the procedure (on the OIE website); Member Country submits to the OIE a dossier providing the information requested (as appropriate) in Chapter 1.6;


Voluntary - applications from OIE Member Countries

OIE Headquarters

OIE ad hoc Groups

OIE Scientific Commission for Animal Diseases

Adoption by OIE World Assembly

Procedure for official recognition of disease status and official control programmes


by adoption of a Resolution

Official recognition - World Assembly

Presenter

Presentation Notes

Voluntary procedure Status for FMD, CBPP, AHS, PPR, CSF and BSE risk Endorsement of official programmes for control of CBPP, FMD and PPR Based on OIE standards Procedure under the responsibility of the OIE Director General, constantly improved Assessment under the mandate of the Scientific Comm


Publication


R. Doisneau

How do I find out if the country I wish to trade with is free from a specific OIE listed disease

of concern to me?

Do they have OIE official

recognition of disease status?

What is their disease status

in WAHIS? present/absent/

not reported

Have they

made a self-declaration of freedom


R. Doisneau

Is my country free from an OIE listed

disease?

Do I want to

Communicate this?


Self-declaration of an OIE listed disease*

Freedom of a country, zone or compartment For OIE listed diseases but… * Not for the 6 diseases for which an official

recognition may be granted Based on requirements in Terrestrial Code Chapters

1.1., 3.1. and 3.2. and provisions of the relevant disease chapters in the

Code and Manual.

40

Presenter

Presentation Notes

A Member Country should develop documentation setting out the compliance of the Veterinary Services with the provisions of Chapters 1.1., 3.1. and 3.2. of the Terrestrial Code and with the provisions of the relevant disease chapter in the Terrestrial Code and the Terrestrial Manual. The Member may wish to transmit this information to OIE Headquarters, which may publish the information. The OIE does not publish self declaration for diseases given official recognition by the OIE


OIE publication of the claim in the

Publication does not imply OIE endorsement of the

claim.

41

World Organisation for Animal Health · Protecting animals, Preserving our future | 42 0 2 4 6 8 10 12 14 16 18 20 22 24 26

Yellowhead disease White spot disease

Viral haemorragic septicaemia Vescicular stomatitis

Taura syndrome Swine Vesicular Disease

Scrapie Rabies

Rabbit haemorrhagic disease Pullorum Disease

Peste des petits ruminants Nipha virus

Newcastle disease Infectious salmon anaemia

Infectious myonecrosis Infectious Laringotracheitis

Infectious haematopoietic necrosis Haemorrhagic septicaemia

Glanders Fowl Typhoid

Foot and mouth disease Equine influenza

Equine arteritis Epizootic haematopoietic necrosis

Classical swine fever Caprine and ovine brucellosis

Bluetongue Avian Influenza

Aujeszky African swine fever

African horse sickness

Number of self-declarations per disease in the World

42

AI

CSF

ASF

Rabies Sw. Ves. Dis.


Highly Pathogenic Avian Influenza

Pakistan Self Declaration as free HPAI 2009

Sri Lanka Self Declaration as free HPAI 2013

Presenter

Presentation Notes

Pakistan – 2009 - Avian Influenza Sri Lanka – 2013 - Avian Influenza


Procedures

44


Part 4

Implementation of OIE Standards - Case study of FMD


Foot and mouth disease standards

FMD Chapter publication timeline

1968 2015 2011

First publication of adopted FMD chapter

The concept of an OIE-endorsed official control programme for FMD has been introduced

Comprehensive revision of the FMD chapter

2018 -

TAHSC proposed revision of the chapter incl. introducing new concept of free compartment with vaccination


Infection with foot and mouth disease virus

• Structure of the chapter: defines the disease for trade purposes;

provides categories for disease freedom and criteria for the recovery of status in the event of the loss of a recognised disease status;

provides risk mitigation measures for the safe trade in commodities;

provides specific surveillance guidelines to prove the absence of disease and infection;

further standards are provided for the official endorsement of national disease control programmes for FMD

Terrestrial Animal Health Code (Chapter 8.8.)


Challenge for FMD standards

Nos Description of trade issue Cause of problems

1 FMD related trade restrictions – limiting sales or distribution of frozen buffalo meat coming from a country with FMD official control programme only to processing sectors in the importing countries

Non-compliance with OIE standards

2 FMD related unjustified trade ban including milk products and non-animal origin products such as dry noodle or textile products

Non-compliance with OIE standards

3 Questions on how to allow imports from neighbouring countries with different FMD status

A lack of sufficient understanding of OIE standards

FMD related STCs raised from June 2016 to May 2017


Challenge for FMD standards

• Importing countries requiring “FMD disease freedom” not accepting OIE’s “safe trade recommendations” OIE recommends trade in fresh meat from free zones w/o vaccination

(Art. 8.8.20.) and from free zones with vaccination (Art. 8.8.21) OIE recommends trade in fresh meat from infected countries/zones

where an official control programme exists (Art. 8.8.22.)

• A previously free country having an incursion of FMD are not able to export until it regains its status free countries having management tools in place such as contingency

plans that in case of FMD incursion could Article 8.8.20. on an official control programme to continue trade

Trade responses to FMD outbreaks


Global FMD control strategy and OIE standards

• The history of FMD outbreaks confirms that the most common spread occurs across national borders and within the more close proximity of regions Reg. approach (e.g. SEACFMD) accepted as proven method to FMD control

• Since 1994, official disease recognition embodied in the Code to give impetus to global freedom. To further facilitate trade, the Code expanded to recognize free zones and compartments and safe commodities

• However, a slow and costly process requires sustainable and effective VS and strong political will

One of the most trade-sensitive and infectious disease

OIE Member Countries’ official FMD status (last update January 2017) :Out of 180 MCs: only 66 MCs free w/o vac., 2 MCs free w/vac., 13 MCs free zones w/o vac. 9 MCs free zones w/vac.


Practical application of FMD standards FMD official control programme

The FAO Progressive Control Pathway for FMD (PCP-FMD)

• At an advanced stage 3 in PCP, Members may request an OIE endorsement of their official control programme

• When requesting such endorsement, the Members shall submit to the OIE Status Department a dossier providing the information requested in Article 1.6.11.

• The benefits of having an OIE-endorsed control programme are that it could provide additional assurance on quality of VS and disease control measures and facilitate trade for certain commodities (Arts. 8.8.12, 8.8.22, 8.8.25.)

OIE endorsed Control

Programmes

Dossier OIE Status


Successful control and implementation of standards

• Global level International community should promote and assist esp.

developing countries to become active participants in the pathway towards global freedom

Regional strategies provide a valuable guide for local implementation of OIE standards

Pilot or twinning programmes can offer good opportunities to tailor implementation choices to fit local needs

• Country level Build VS capacity to update legislation Improve understanding and `ownership` of OIE standards Budget support for VS

Essential elements of control and implementation strategy


Conclusions

WTO recognized OIE as relevant standard-setting body relating to animal health and zoonoses

Terrestrial Code is a living document continue to evolve and updated with scientific advancement each year, new or revised standards are proposed for

adoption at the General Session Key SPS concepts (e.g. RA, zoning, equivalence) are fully

employed to facilitate safe trade The application of OIE standards is the best means of

avoiding disagreements, disputes and other problems in international trade

Take home message


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trade in animal products opportunities and … · against rabies . bse-related restrictions . world...

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