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Sanitary & Phytosanitary
Introduction to the WTO SPS Agreement

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‣ The Agreement defines its scope as a function of the objective of the
measure, i.e. food safety and animal and plant health protection, as
opposed to the type of measure. Consequently, products, processes
and production methods are equally covered by its provisions.
For example, slaughterhouses must comply with strict sanitary standards if the end-users are to receive
safe meat products. Any discrimination among foreign suppliers must be justified on the basis of their
animal and plant health conditions.
Unlike the AoA, the SPS Agreement does not create schedules of binding obligations.
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Four defined circumstances (Annex A)
‣ 1. “Protection of human or animal life or health from risks arising from
additives, contaminants, toxins or disease-causing organisms in their food”.
Other human health risks, such as nutrition concerns, medical treatments, or
general safety risks, do not fall within this category.
‣ 2. “Protection of human life from plant- or animal-carried diseases.”
‣ 3. “Protection of animal or plant life from the introduction of pests, diseases
or disease-causing organisms.” An import ban on live cattle originating from
herds infected by Bovine tuberculosis would be one example
‣ 4. “Protection of a country from damage caused by the entry, establishment or
spread of pests.” That is, protection against invasive species
The protection of fish, wild fauna, forests and wild flora are
covered by the Agreement but the protection, for example of the
environment as such or animal welfare are excluded.
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Nature of approved SPS measures
Sanitary measures may take many different forms (Annex A) such as:
‣ requiring products to come from disease-free areas or submit to quarantine,
‣ imposing specific product or process criteria, certification or inspection procedures, sampling and testing
requirements, health-related labelling measures,
‣ setting of permissible maximum levels of pesticide residues, or permitted use of only certain additives in
food.
Measures may be imposed on non-agricultural products; e.g. restrictions on paints used on dishes to ensure that
food is not contaminated are also SPS measures. Although the measure may be imposed outside the territory of the
importing country — e.g. processing requirements or certification — its purpose must be to protect health within the
territory of the importing country.
Members have the right to take SPS measures (other than the application of an international standard) based on
scientific evidence but the qualifications that apply to the general exceptions of GATT Art. XX(b) also apply to SPS
measures. Measures must be
‣ no more trade restrictive than necessary to protect health,
‣ not arbitrarily or unjustifiably discriminate between Members where identical or similar conditions prevail
‣ must not be applied in a manner which would constitute a disguised restriction on international trade.
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Contents and the “three Sisters”
Preamble
Art. 1 General Provisions FAO/WHO Codex Alimentarius
The Codex Alimentarius Commission, based in Rome, is a subsidiary organ of the Food
Art. 2 Basic Rights and Obligations and Agriculture Organization of the United Nations (FAO) and the World Health
Art. 3 Harmonization Organization (WHO). The SPS Agreement designates Codex as the authority for all matters
related to international food safety evaluation and harmonization. Several Codex activities
Art. 4 Equivalence relate to the evaluation of food-borne hazards, although Codex also develops non-health
Assessment of Risk and Determination of the Appropriate Level of
related technical food standards, like nutrition, composition, and quality standards. Codex
Art. 5 develops scientific methodologies, concepts and standards to be used world-wide for food
Sanitary or Phytosanitary Protection
additives, microbiological contaminants, veterinary drug and pesticide residues to be used
Art. 6
Adaptation to Regional Conditions, Including Pest- or Disease- Free world-wide. It has also developed useful references like the "General Principles on Food
Areas and Areas of Low Pest or Disease Prevalence Hygiene" and the "General Principles on Meat Hygiene".
Art. 7 Transparency
Art. 8 Control, Inspection and Approval Procedures
World Organization for Animal Health (OIE)
The OIE's "International Animal Health Code" and "Aquatic Animal Health Code" offer
Art. 9 Technical Assistance international animal health standards and procedures that are periodically amended to take
into account the latest scientific research. The OIE develops manuals on: animal diseases;
Art. 10 Special and Differential Treatment standards for diagnosis, vaccination, epidemiological surveillance, disease control and
Art. 11 Consultations and Dispute Settlement eradication; procedures such as disinfection and certification; and laboratory equipment.
Art. 12 Administration
International Plant Protection Convention (IPPC)
Art. 13 Implementation A subsidiary body of the FAO. Its main objectives are to take specific actions to prevent the
Art. 14 Final Provisions introduction and spread of plant pests, and to promote measures for pest control, including
information exchange. It has developed region-specific lists of plant pests. The IPPC
Annex A Definitions develops international plant import health standards, principally on quarantine pests, a
"Glossary of Phytosanitary Terms", basic principles governing phytosanitary laws and
Annex B Transparency of SPS Regulations
regulations, and harmonized plant quarantine procedures.
Annex C Control, Inspection and Approval Procedures

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Harmonization
‣ Before the entry into force of the WTO, international standards,
guidelines, recommendations and other advisory texts could be
adopted by governments on a voluntary basis.
‣ The SPS Agreement confers a new status on standards promulgated the
the “three sisters” that, however, remain voluntary. Members adopting
them are presumed to be in full compliance with the SPS Agreement.
‣ A Member may decide to establish protection levels that exceed
international standards if there is a scientific justification or if it
determines that the standard does not meet its acceptable level of
protection.
‣ When a Member decides not to use an international standard, however,
its measure must be based on a proper risk assessment and is subject
to a range of other conditions set out in detail in Article 5 of the
Agreement
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Equivalence
The Agreement recognizes that there may be different ways
of ensuring SPS protection in different countries.
‣ It provides that WTO Members should accept another's procedures as
equivalent whenever the same level of human, animal or plant health
protection is achieved.
‣ Agreements acknowledging the equivalence of health protection
measures enforced by different approaches must be negotiated on a
bilateral or regional basis.
The exporting country bears the burden of demonstrating that its sanitary treatments are equivalent to
those of the importing country. The exporter must supply relevant information that the importer may
need to form its judgement, including access to its health authorities, facilities, equipment and
procedures.
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Risk assessment
‣ Risk assessments may be qualitative or quantitative.
‣ Members must establish SPS measures on the basis of an evaluation of the actual
risks involved including an economic evaluation of alternative risk management
strategies.
“...Members shall take into account available scientific evidence; relevant processes and production methods;
relevant inspection, sampling and testing methods; prevalence of specific diseases or pests; existence of pest- or
disease-free areas; relevant ecological and environmental conditions; and quarantine or other treatment.” (Article 5.2)
“...Members shall take into account as relevant economic factors: the potential damage in terms of loss of production
or sales in the event of the entry, establishment or spread of a pest or disease; the costs of control or eradication in
the territory of the importing Member; and the relative cost-effectiveness of alternative approaches to limiting
risks.” (5.3)
‣ Members must not use more-restrictive measures than necessary
“...Members shall ensure that such measures are not more trade-restrictive than required to achieve their appropriate level of
sanitary or phytosanitary protection, taking into account technical and economic feasibility” (5.6)
‣ The WTO Appellate body has directed panels to defer to Members’ judgement on
the ALOP but in Australia-Apples it required the Panel to make it’s own
assessment of whether a measure was more trade restrictive than necessary
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The “appropriate level of protection”
Members have the right to determine an appropriate level of health
protection (ALOP)
‣ In effect a level of “risk aversion”
‣ Should be a reflection of health protection, not a means to protect domestic producers
from competition
‣ May vary according to circumstances (e.g. between plants and animals or fish health)
‣ Where the health risks are similar, the acceptable level of protection should be
similar, if any distinction would result in discrimination or a disguised restriction on
international trade.
Risk = probability of occurrence * impact of the event
Once the government has determined its appropriate level of sanitary and phytosanitary
protection, it must not choose a measure that is more stringent or more trade-restrictive
than needed to moderate the risk down to the ALOP.
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“Provisional” measures
‣ The Agreement (Art. 5 (7)) permits Members to take “provisional” measures based on
available “pertinent information” in cases of emergency and when sufficient scientific
evidence does not yet exist to support definitive measures.
For example, following the BSE scare in 1996, and in the absence of sufficient scientific evidence,
several Members introduced emergency import bans.
‣ This is not an endorsement of the “precautionary principle” (whatever that is).
‣ The emergency measures must only be provisional.
In Japan - Agricultural Products II, the Appellate Body said: “... such a provisional
measure may not be maintained unless the Member which adopted the measure:
(1) ‘seek[s] to obtain the additional information necessary for a more objective assessment of
risk’; and
(2) ‘review[s] the … measure accordingly within a reasonable period of time’.
These four requirements are clearly cumulative in nature and are equally important for the
purpose of determining consistency with this provision. Whenever one of these four
requirements is not met, the measure at issue is inconsistent with Article 5.7.”
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Regionalization (Art. 6)
‣ Governments should recognize disease- or pest-free areas that might
correspond to only part of a country or might cover parts of several
countries.
Product requirements should be adapted to suit those regions.
‣ The burden of demonstrating disease-free status falls on the exporting
Member (as with the principle of equivalence). The exporting country
must allow experts from the importing country to inspect the area
concerned and the controls in place to check the disease from
spreading.
The OIE has developed procedures for evaluating disease-free status
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Transparency
‣ National Notification Authority
Each WTO Member must designate a national central government authority as responsible for the implementation of
the notification procedures. Whenever a government intends to put into effect a new sanitary or phytosanitary
regulation, or modify an existing law that may restrict trade and differs from an international standard, it must notify
the WTO Secretariat.
‣ National Enquiry Point
Governments must also set up national "enquiry points" whose task is to provide to their trading partners any
information requested on the application of food safety and animal and plant health regulations, the existence of
equivalence agreements, or information on risk assessment procedures and decisions.
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Notification
‣ Regular procedures: Members must inform their trading partners,
through the WTO Secretariat, of proposed new or modified national
sanitary and phytosanitary regulations in time to give trading partners
60 days in which to comment on proposed regulations.
The notification must specify the competent authorities and the agency responsible for promulgating the
regulation and the products covered. Members must indicate whether a relevant international standard
exists, whether a measure is based on such a standard, and if not, how it deviates from it. Members
must provide as part of the notification the full title and a brief abstract of the regulation as well as an
indication of the language in which the document is available and contact details for the agency handling
comments.
‣ Emergency procedures: A notification must be made upon
implementation, using the special format developed for this purpose.
The nature of the urgent problem must be clearly stated, and a period for its application must be
identified. Comments may still be received from WTO Members concerned. Eventually, an emergency
measure must be supported by an appropriate risk assessment and the government must stand ready to
provide a scientific justification for maintaining the measure.
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Dispute settlement
‣ The SPS Agreement is subject to the WTO Dispute Settlement
procedures.
During the course of the deliberations over a sanitary or phytosanitary trade measure, the panel may
seek advice on scientific or technical issues, as it sees appropriate (many have). Such advice can be
sought from individual experts, a group of technical experts, or a relevant international organization.
‣ Alternative dispute settlement procedures
Some of the international standard-setting organizations such as the IPPC, have their own procedures
through which countries can settle their differences. The SPS Agreement does not limit the right of
governments to use these dispute settlement procedures rather than those of the WTO. Similarly,
Members of a regional organization, such as NAFTA, could choose to take SPS-related matters to that
agreement’s dispute settlement mechanisms
‣ Since 1 January 1995, almost 40 cases involving sanitary and
phytosanitary measures have reached the Panel stage of adjudication (6
involving Australia as a respondent)
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Developing members
‣ The SPS Committee may grant longer time-frames for compliance with
some or all of the obligations under the Agreement upon request.
‣ The Agreement calls for technical assistance to developing country
Members to enable them to strengthen their food safety and animal and
plant health protection. Members are encouraged to provide technical
assistance on a bilateral basis or through other international
organizations.
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