The Uruguay Round's Sanitary and
Phytosanitary (SPS) Agreement establishes a multilateral mechanism to
protect human, animal, and plant health in World Trade Organization (WTO)
member countries. As a WTO member, this Agreement protects U.S. exporters
from other countries’ use of health‑related measures to disguise barriers to
Definition of an SPS Measure:
In the context of the SPS Agreement, SPS measures refer to any measure,
procedure, requirement, or regulation, taken by governments to protect
human, animal, or plant life or health from the risks arising from the
spread of pests, diseases, disease‑causing organisms, or from additives,
toxins, or contaminants found in food, beverages, or feedstuffs.
History of the Agreement:
Virtually all countries, including the United States, supported the
development of new and strengthened SPS rules in the Uruguay Round. Before
the Uruguay Round, trade rules for SPS measures were so vague that countries
could protect domestic producers from international competition by
establishing import restrictions justified only by the country's assertion
that the measure existed for "health reasons." These restrictions were of
particular significance for U.S. agriculture, as countries could cite
unfounded risks of a pest or disease as reason to keep out U.S. exports.
With the Uruguay Round’s removal of other agricultural market access
barriers, rules for disciplining the use of SPS measures became even more
The SPS Agreement contains 14
articles and three annexes covering basic rights and obligations;
harmonization; equivalency; risk assessments; pest- or disease-free areas;
transparency; control, inspection, and approval procedures; technical
assistance; special and differential treatment; consultations and dispute
settlement; administration; and implementation.
Since the inception of the
Agreement in 1995, the WTO Committee for SPS Measures (formed in accordance
with Article 12 of the Uruguay Round Agreement on SPS Measures) has met at
least three times each year and addressed more than 204 trade issues from
1995 to 2004.
Core Disciplines: To
eliminate disguised trade restrictions, the Agreement allows countries to
set their own standards. SPS measures must be based on science. They should
be applied only to the extent necessary to protect human, animal or plant
life, or health. The regulations should not arbitrarily or unjustifiably
discriminate between countries where identical or similar conditions
prevail. The nature and magnitude of the perceived risk must be clearly
established so that the SPS measure is commensurate with the risk. The
Agreement also contains procedures for managing risk to limit unnecessary
restrictions on international trade. Countries are encouraged to establish a
consistent approach to the concept of appropriate levels of protection and
to allow imports when the exporting country objectively demonstrates that it
has controlled possible risks. Finally, countries must notify their trading
partners when they intend to establish SPS measures and seek their comments
on proposed laws. Important principles incorporated into the SPS text
include the following.
Basic SPS Rights: Article 2
of the SPS Agreement recognizes the sovereign right of each country to set
its own food safety, and animal and plant health standards. While
encouraging countries to use international standards, the SPS text clearly
recognizes that, under certain circumstances, countries have the right to
maintain standards that are stricter than international standards to protect
human, animal, and plant health, as long as the more stringent standard is
justified by science. In addition, while all SPS measures must be based on a
risk assessment, a country has the right to decide the appropriate level of
risk, subject to the condition that any arbitrary or unjustified distinction
does not result in discrimination or a disguised restriction on trade.
Harmonization: Article 3 of
the SPS Agreement recognizes the Codex Alimentarius Commission (CODEX), the
International Office of Epizootics (OIE), and the International Plant
Protection Convention (IPPC) for their expertise in setting standards. The
Agreement states that harmonization between nations will be promoted by
following the standards set by these three international scientific
Equivalency: Article 4
recognizes that different methods may be used to achieve the same level of
health protection. If an exporting country’s measures achieve the importing
member’s appropriate level of sanitary and phytosanitary protection, then
those measures may be acceptable, even if they differ from those used by the
Risk Assessment: Article 5
of the Agreement covers assessment of risk and determination of the
appropriate level of SPS protection. A risk assessment is the technical
assessment of the nature and magnitude of risk. It involves an effort to
quantify the specific level of risk posed by a substance or situation.
Countries are obligated to ensure that SPS measures are based on risk
assessment, taking into account techniques developed by the relevant
Pest‑ or Disease‑Free Status:
As addressed in Article 6, pest- or disease-free status has
traditionally been considered on a country‑by‑country basis or by political
boundaries. The SPS text establishes an "area within a country" or a
"regionalization" approach. In other words, exports should be possible from
a particular area within a country if a country can demonstrate that the
area is, and is likely to remain, free of a pest or disease, even if the
surrounding areas of the country are not free of the pest or disease.
transparency provisions of the Agreement are outlined in Article 7 and Annex
B. Transparency refers to the manner in which health‑related measures are
formulated and adopted by countries. Since the inception of the Agreement,
members have notified over 5,000 SPS measures. Countries should notify the
WTO of any changes in health‑related measures that may have a significant
impact on trade. Countries are to set up offices called “Enquiry Points” to
respond to requests for additional information on new or existing measures.
Sanitary and Phytosanitary
Committee: To administer the Agreement, Article 12 created the WTO
Committee for SPS Measures. This committee serves as a forum for
consultations between countries on specific SPS issues.
Dispute Settlement: If an
exporting country believes an importing country has an unjustified SPS
measure, it can first raise the issue in the WTO Committee for SPS Measures.
If the exporting country believes no results have been achieved in this
venue, it may, under Article 11, use the dispute settlement mechanism of the
WTO. This entails consultations between the countries. If no agreement is
reached, the issue can be decided by an impartial panel of trade experts.
The SPS Agreement encourages the panel to seek technical expertise. If the
panel determines that the SPS measure is inconsistent with WTO rules, the
importing country must either change the measure or negotiate some form of
compensation to the country or countries adversely affected by the
unjustified measure. If the importing country fails to make either of these
remedies, the complainant will be authorized to retaliate through the WTO
Four SPS Issues Elevated to
Dispute Settlement Panels: Since 1995, four cases have gone through the
dispute settlement process. They are the United States vs. the European
Union (EU) on beef hormones, Canada vs. Australia on salmon, the United
States vs. Japan on fruit varietals, and the United States vs. Japan
Measures Affecting the Importation of Apples.
The United States vs. the EU on
In 1985, the EU banned the sale of
U.S. beef from cattle treated with certain growth hormones. The United
States contested the prohibition first under the General Agreement on
Tariffs and Trade and then under the new WTO dispute resolution mechanism.
In 1997, a dispute settlement panel ruled that the EU ban violated the SPS
Agreement. The EU appealed this finding.
In 1998, the WTO Appellate Body
upheld most of the panel’s findings against the EU, making three points:
All the available scientific
evidence, including that presented by the EU, as well as by experts
consulted by the panel, indicated that the hormones were safe.
The Appellate Body upheld the
determination that the EU had failed to conduct a risk analysis to meet
its obligations under Article 5 of the SPS Agreement.
The concept of precaution,
although represented in Article 5.7 of the SPS Agreement, does not
override any stated obligations, especially not those in Articles 5.1
Canada vs. Australia on Salmon
In 1975, Australia imposed an
import restriction requiring that fresh, chilled, and frozen salmon could
enter Australia only after first having been heat treated. In 1995, arguing
that the import restrictions violated the SPS Agreement, Canada requested
Article 4.4 consultations.
In March 1997, Canada called for
creation of a dispute settlement panel, and the United States reserved the
right to participate as a third party. The panel decided that Australia, by
conducting a risk assessment limited to certain types of salmon, had
maintained a measure not based on a correct risk assessment and had not met
its obligations under Articles 5.1 and 2.2 of the SPS Agreement.
The Appellate Body upheld most of the
panel's findings against Australia, making two points:
Australia limited its import ban
to salmon, while tolerating imports of herring used as bait and live
ornamental fish. Both posed an equal or greater risk of spreading disease to
the very domestic stocks that the salmon ban ostensibly protected.
Australia had no controls on the
internal movement of salmon products when compared with the import
prohibition on ocean-caught Pacific salmon.
United States vs. Japan on
In October 1997, the United States
brought a formal WTO complaint against Japan for prohibiting imports of fresh
apricots, cherries, plums, pears, quince, peaches, apples, and walnuts from the
continental United States because the fruits were potential hosts for the
Though common in the United States,
this moth is a quarantined pest in Japan. The Japanese rule contained a general
exception permitting entry of the products on a variety-by-variety basis, a
costly and slow process. The United States urged the dispute settlement panel to
find that these measures were not based on science or international standards.
In October 1998, the panel agreed with
the U.S. interpretation, making the following points:
Japan had violated Article 2.2 by maintaining the same
quarantine provisions for all these fruit varieties and not identifying the
risks specifically enough.
Japan had violated Article 5.6 by using more
trade-restrictive varietal testing requirements than were necessary. The
panel noted that Japan could have protected itself from the coddling moth by
setting a certain fumigant concentration level when treating affected
Japan had violated Article 7 by failing to publish its
United States vs. Japan Measures
Affecting the Importation of Apples
In 2002, Japan prohibited the import
of apples from orchards where fire blight had been detected. Also, Japan
required that export orchards be inspected three times yearly for the presence
of fire blight and any orchard would be disqualified from exporting to Japan if
fire blight was detected within a 500-meter buffer zone.
In 2003, a dispute settlement panel
ruled that Japan’s phytosanitary measure imposed on imports of apples from the
United States was contrary to Article 2.2 of the SPS Agreement, that the measure
was not justified under article 5.7 of the SPS Agreement, and that Japan’s 1999
Pest Risk Assessment did not meet the requirements of Article 5.1 of the SPS
The Appellate Body upheld the Panel’s
finding in 2003 making two points:
Japan's phytosanitary measure at issue was inconsistent
with Japan’s obligations under articles 2.2, 5.7, and 5.1 of the SPS
If the United States only exports mature, symptomless
apples, the alternative measure proposed by the United States meets the
requirement of Article 5.6 of the SPS Agreement.
For more information, contact:
Food Safety and Technical Services
Foreign Agricultural Service
U.S. Department of Agriculture
Ag Stop 1027
1400 Independence Ave., SW
Washington, DC 20250‑1027
Tel.: (202) 720-1301
Fax: (202) 690-0677
about FAS programs, resources, and services is available on the Internet at the
FAS home page: http://www.fas.usda.gov