WORLD TRADE
ORGANIZATIONG/SPS/GEN/406
19 June 2003
(03-3281)
Committee on Sanitary and Phytosanitary Measures Original:  English/
                 French/                 Spanish
GUIDELINES FOR REACHING A JUDGEMENT OF EQUIVALENCE OF
SANITARY MEASURES
Submission by the Office International des Épizooties
The following reproduces the text of Chapter 1.3.7. of the 2003 OIE Terrestrial Animal
Health Code.
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Article 1.3.7.1.
Introduction
The importation of animals  and animal products involves a degree of risk to the animal health
status of an importing country .  The estimation of that risk and the choice of the appropriate risk
management option(s) are made more difficult by differences among the animal health and production
systems in OIE member countries.  It is now recognized that significantly different animal health and
production systems can provide equivalent animal and human health protection for the purpose of
international trade , with benefits to both the importing and exporting  country .
These guidelines are to assist OIE Member Countries to determine whether sanitary measures
arising from different animal health and production systems may provide the same level of animal and
human health protection.  They discuss principles which might be utilized in a judgement of
equivalence, and outline a step–wise process for trading partners to follow in facilitating a judgement
of equivalence.  These guidelines are applicable whether equivalence applies at the level of specific
measures or on a systems–wide basis, and whether equivalence applies to specific areas of trade orcommodities , or generally.
Article 1.3.7.2.
General considerations
Before trade in animals  or their products may occur, an importing country  must be satisfied
that its animal health status will be appropriately protected.  In most cases, the risk management
measures drawn up will rely in part on judgements made about the animal health and production
system(s) in the exporting country  and the effectiveness of sanitary procedures undertaken there.
Systems operating in the exporting country  may differ from those in the importing country  and from
those in other countries with which the importing country  has traded.  Differences may be with
respect to infrastructure, policies and/or operating procedures, laboratory systems, approaches to the
pests and diseases present, border security and internal movement controls.
International recognition of the legitimacy of different approaches to achieving the importing
country 's appropriate level of protection (ALOP) has led to the principle of equivalence being
included in trade agreements, including the Agreement on Application of Sanitary and Phytosanitary
Measures (the so-called SPS Agreement) of the World Trade Organization (WTO).G/SPS/GEN/406
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Benefits of applying equivalence may include:
1. minimizing costs associated with international trade  by tailoring animal health
measures to local circumstances;
2. maximizing animal health outcomes for a given level of resource input;
3. facilitating trade by achieving the required health protection through less trade
restrictive sanitary measures;  and
4. decreased reliance on relatively costly commodity  testing and isolation procedures in
bilateral or multilateral agreements.
The Terrestrial  Code  recognizes equivalence by recommending alternative sanitary measures
for many diseases.  Equivalence may be gained, for example, by enhanced surveillance and
monitoring, by the use of alternative test, treatment or isolation procedures, or by combinations of the
above.  To facilitate the judgement of equivalence, member countries are encouraged to base theirsanitary measures on OIE standards, guidelines and recommendations to the extent possible.
It is essential to apply the discipline of risk assessment (the primary scientific component of
risk analysis) to the extent practicable in establishing the basis for a judgement of equivalence.
Article 1.3.7.3.
Definitions
For the purposes of these guidelines, the following definitions apply:
Appropriate level of protection  (ALOP ) (acceptable risk) :  The level of protection deemed
appropriate by the country establishing a sanitary measure to protect human or animal life or healthwithin its territory.
Equivalence of sanitary measures :  The state wherein the sanitary measure(s) proposed by the
exporting  country  as an alternative to those of the importing  country , achieve(s) the same level of
protection.
Hazard :  A biological, chemical or physical agent in, or a condition of, an animal  or animal product
with the potential to cause an adverse health effect.
Risk :  The likelihood of the occurrence and the likely magnitude of the consequences of an adverse
event to animal or human health in the importing  country  during a specified time period, as a result
of a hazard.
Risk analysis :  The process composed of hazard identification, risk assessment, risk management and
risk communication.
Risk assessment :  The evaluation of the likelihood and the biological and economic consequences of
entry, establishment, or spread of a pathogenic agent within the territory of an importing country .
Sanitary measure :  Any measure applied to protect animal or human health or life within the
territory of the member country from risks arising from the entry, establishment or spread of a hazard.[Note: A detailed definition of sanitary measure may be found in the WTO SPS Agreement. ]G/SPS/GEN/406
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Article 1.3.7.4.
Prerequisite considerations in a judgement of equivalence
1. Application of risk assessment
Application of the discipline of risk assessment provides a structured basis for judging
equivalence among different sanitary measures as it allows a close examination to be made of
the effect of a measure(s) on a particular step(s) in the importation pathway, and the relativeeffects of proposed alternative measure(s) on the same or related steps.
A judgement of equivalence needs to assess the sanitary measure in terms of its effectiveness
regarding the particular risk or group of risks against which the measure is designed toprotect.  Such an assessment may include the following elements: the purpose of the measure,
the level of protection achieved by the measure and the contribution the measure makes to
achieving the ALOP of the importing country .
2. Categorisation of sanitary measures
Proposals for equivalence may be in terms of a measure comprising a single component of a
measure (e.g. an isolation procedure, a test or treatment requirement, a certification
procedure) or multiple components (e.g. a production system for a commodity), or a
combination of measures.  Multiple components or combinations of measures may be applied
consecutively or concurrently.
Sanitary measures are those described in each Chapter of the Terrestrial  Code  which are used
for risk reduction and are appropriate for particular diseases.  Sanitary measures may be
applied either alone or in combination and include test requirements, processing requirements,inspection or certification procedures, quarantine confinements, and sampling procedures.
For the purposes of judging equivalence, sanitary measures can be broadly categorized as:
(a) infrastructure: including the legislative base (e.g. animal health law) and administrative
systems (e.g. organization of national and regional animal health authorities,emergency response organizations);
(b) programme design/implementation: including documentation of systems, performance
and decision criteria, laboratory capability, and provisions for certification, audit and
enforcement;
(c) specific technical requirement: including requirements applicable to the use of secure
facilities, treatment (e.g. retorting of cans), specific test (e.g. ELISA) and procedures(e.g. pre–export inspection).
A sanitary measure(s) proposed for a judgement of equivalence may fall into one or more of
these categories, which are not mutually exclusive.
In some cases a comparison of specific technical requirements may suffice.  In many
instances, however, a judgement as to whether the same level of protection is likely to beachieved may only be able to be determined through an evaluation of all relevant components
of an exporting  country 's animal health and production system.  For example, a judgement of
equivalence for a specific sanitary measure at the programme design/implementation level
may require a prior examination of infrastructure while a judgement of equivalence for a
specific measure at the specific technical requirement level may require that the specificmeasure be judged in its context through examination of infrastructure and programmes.G/SPS/GEN/406
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Article 1.3.7.5.
Principles for judgement of equivalence
In conjunction with the above considerations, judgement of the equivalence of sanitary
measures should be based on application of the following principles:
1. an importing country  has the right to set the level of protection it deems appropriate
(its ALOP) in relation to human and animal life and health in its territory; this ALOP
may be expressed in qualitative or quantitative terms;
2. the importing  country  should be able to describe the reason for each sanitary measure
i.e. the level of protection intended to be achieved by application of the identified
measure against a hazard;
3. an importing country  should recognize that sanitary measures different from the ones
it has proposed may be capable of providing the same level of protection;
4. there are benefits in applying the concept of equivalence to animal health and
production systems;
5. countries should, upon request, enter into consultations with the aim of facilitating a
judgement of equivalence;
6. any sanitary measure or combination of sanitary measures can be proposed for
judgement of equivalence;
7. an interactive process should be followed that applies a defined sequence of steps, and
utilises an agreed process for exchange of information, so as to limit data collection to
that which is necessary, minimise administrative burden, and facilitate resolution of
claims;
8. the exporting country  should be able to demonstrate objectively how the alternative
sanitary measure(s) proposed as equivalent will provide the same level of protection;
9. the exporting country  should present a submission for equivalence in a form that
facilitates judgement by the importing country ;
10. the importing country  should evaluate submissions for equivalence in a timely,
consistent, transparent and objective manner, and according to appropriate risk
assessment principles;
11. the importing country  should take into account any knowledge of and prior
experience with the Veterinary Administration  or other competent authority of the
exporting country ;
12. the exporting country  should provide access to enable the procedures or systems
which are the subject of the equivalence judgement to be examined and evaluated
upon request of the importing country ;
13. the importing country  should be the sole determinant of equivalence, but should
provide to the exporting  country  a full explanation for its judgement;
14. to facilitate a judgement of equivalence, Member Countries should base their sanitary
measures on relevant OIE standards;
15. to allow the judgement of equivalence to be reassessed if necessary, the importing
and exporting countries  should keep each other informed of significant changes to
infrastructure, health status or programmes which may bear on the judgement of
equivalence; andG/SPS/GEN/406
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16. an importing country  should give positive consideration to a request by an exporting
developing country for appropriate technical assistance that would facilitate the
successful completion of a judgement of equivalence.
Article 1.3.7.6.
Sequence of steps to be taken in judgement of equivalence
There is no single sequence of steps which must be followed in all judgements of
equivalence.  The steps that trading partners choose will generally depend on the circumstances and
their trading experience.  The interactive sequence of steps described below may be useful for all
sanitary measures irrespective of their categorization as infrastructure, programmedesign/implementation or specific technical requirement components of an animal health andproduction system.
This sequence assumes that the importing country  is meeting its obligations under the WTO
SPS Agreement and has in place a transparent measure based either on an international standard or arisk analysis.
Recommended steps are:
1. the exporting country  identifies the measure(s) for which it wishes to propose an
alternative measure(s), and requests from the importing  country  a reason for its
sanitary measure in terms of the level of protection intended to be achieved against a
hazard(s);
2. the importing country  explains the reason for the measure(s), in terms which would
facilitate comparison with an alternative sanitary measure(s) and consistent with theprinciples set out in these guidelines;
3. the exporting country  demonstrates the case for equivalence of an alternative sanitary
measure(s) in a form which facilitates analysis by an importing country ;
4. the exporting country  responds to any technical concerns raised by the importing
country  by providing relevant further information;
5. judgement of equivalence by the importing  country  takes into account as appropriate:
(a) the impact of biological variability and uncertainty;
(b) the expected effect of the alternative sanitary measure(s) on all relevant hazards;
(c) OIE standards;
(d) application of solely qualitative frameworks where it is not possible or
reasonable to conduct quantitative risk assessment;
6. the importing country notifies the exporting country of its judgement and the
underlying reasons within a reasonable period of time:
(a) recognition of the equivalence of the exporting country's alternative sanitary
measure(s);
(b) request for further information; or
(c) rejection of the case for equivalence of the alternative sanitary measure(s);
7. an attempt should be made to resolve any differences of opinion over judgement of a
case, either interim or final, by using an agreed mechanism to reach consensus (e.g. the
OIE dispute settlement mechanism), or by referral to an agreed expert;G/SPS/GEN/406
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8. depending on the category of measures involved, the importing and exporting countries
may enter into a formal equivalence agreement giving effect to the judgement or a less
formal acknowledgement of the equivalence of a specific measure(s) may suffice.
An importing country  recognising the equivalence of an exporting  country 's alternative
sanitary measure(s) needs to ensure that it acts consistently with regard to applications from third
countries for recognition of equivalence applying to the same or very similar measure(s).  Consistent
action does not mean however that a specific measure(s) proposed by several exporting  countries
should always be judged as equivalent as a measur e(s) should not be considered in isolation but as
part of a system of infrastructure, policies and procedures.
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