Challenges in implementing the SPS Agreement Gretchen Stanton Agriculture and Commodities Division.

Challenges in implementing the SPS Agreement

Gretchen StantonAgriculture and Commodities

Division

Key Provisions of the SPS AgreementKey Provisions of the SPS Agreement

1. Non-discrimination

2. Scientific justification • harmonization

• risk assessment

• consistency

• least trade-restrictiveness

3. Equivalence

4. Regionalization

5. Transparency

6. Technical assistance/special treatment

7. Control, inspection and approval procedures

DISPUTE

Sci. justification ( 5.7) X (5.7) X (5.7) X (5.7)

Harmoniz. X

Risk Assess. X X X X

Consistency X X

Least trade restrictive

Transparency X X

Annex C approvals

Not yet examined: equivalence, regionalization

1. Non-discrimination2. Scientific justification

• harmonization• risk assessment• consistency• least trade-restrictiveness

3. Equivalence4. Regionalization5. Transparency6. Technical assistance/special

treatment7. Control, inspection and approval

procedures

– Whose science?– How long?– What is justifiable?– What ALOP?

Article 2.2Article 2.2

Members shall ensure that any sanitary or phytosanitary measure is applied only to the extent necessary to protect human, animal or plant life or health, is based on scientific principles and is not maintained without sufficient scientific evidence, except as provided for in paragraph 7 of Article 5.

• Members shall ensure that their sanitary and phytosanitary measures do not arbitrarily or unjustifiably discriminate between Members where identical or similar conditions prevail, including between their own territory and that of other Members. Sanitary and phytosanitary measures shall not be applied in a manner which would constitute a disguised restriction on international trade.

Scientific Justification – Art. 2.2Scientific Justification – Art. 2.2

Sufficient evidence

Rational relationshipCase-by-case: Measure at issueQuality and quantity of science

“... to be ‘maintained without’ sufficient scientific evidence, there needs to be a lack of an objective relationship between, on the one hand, the phytosanitary measure at stake (in casu, the varietal testing requirement) and, on the other hand, the scientific evidence submitted before the Panel (in casu, in particular the six studies referred to by Japan)”.

Scientific justification – Art. 2.2Scientific justification – Art. 2.2

“Negligible risk” vs. zero risk

Sufficient scientific evidence of ability to establish in natural conditions

The studies did not demonstrate • that latent infection in mature, symptomless apples could occur in real orchard conditions• that apple fruit would be likely to complete the pathway and contaminate host plants in Japan under non-laboratory conditions

In cases where relevant scientific evidence is insufficient, a Member may provisionally adopt sanitary or phytosanitary measures on the basis of available pertinent information, including that from the relevant international organizations as well as from sanitary or phytosanitary measures applied by other Members. In such circumstances, Members shall seek to obtain the additional information necessary for a more objective assessment of risk and review the SPS measure accordingly within a reasonable period of time.

Hormones – Precautionary principleHormones – Precautionary principle

• The EC did not invoke Article 5.7 - import prohibition was not a provisional measure

• The EC invoked the “precautionary principle” as a general principle of law and argued that Articles 5.1 and 5.2 did not prevent Members from being cautious when setting health standards in the face of conflicting scientific evidence and uncertainty.

• Precautionary principle does not override obligation to base measure on risk assessment; precautionary principle reflected in SPS Art.5.7

Varietals – Article 5.7 Varietals – Article 5.7 4 Cumulative requirements in order to use Art. 5.7

Members may provisionally adopt SPS measures only when relevant scientific information is insufficient on the basis of available information

In such circumstances, Members must seek to obtain additional information to assess risk review the measure within a reasonable period of

Varietals – Article 5.7 Varietals – Article 5.7

Measure not justified as provisional measure under Art. 5.7

• Japan did not actively seek more scientific evidence in order to do risk assessment

• Did not revise measure within “reasonable period of time” (5 years since entry into force of SPS Agreement)

Apples – Article 5.7 Apples – Article 5.7

Not justified as a provisional measure

(Art. 5.7)

• Sufficient scientific evidence exists to do risk assessment

• Scientific uncertainty does not justify measure under Art. 5.7

GMOs – Article 5.7GMOs – Article 5.7

EC member State bans Art. 5.7 inapplicable

• Sufficient scientific evidence exists for EC risk assessments

• ALOP does not determine sufficiency of evidence

• Need evidence that what was once sufficient evidence is now insufficient

Discussions in the CommitteeDiscussions in the Committee

• “reasonable” test – if disease outbreak, new situation, etc (BSE, AI)

• Emergency measures not based on international standards

• Excessive reactions• Emergency measures maintained despite

sufficient evidence

procedures

– Who sets agenda?– Developing country

participation?– Minimum vs.

maximum requirements

– How long?– Right to exceed ….

To harmonize sanitary and phytosanitary measures on as wide a basis as possible, Members shall base their sanitary or phytosanitary measures on international standards, guidelines or recommendations, where they exist, except as otherwise provided for in this Agreement, and in particular in paragraph 3.

Sanitary or phytosanitary measures which conform to international standards, guidelines or recommendations shall be deemed to be necessary to protect human, animal or plant life or health, and presumed to be consistent with the relevant provisions of this Agreement and of GATT 1994.

Article 3.3Article 3.3Members may introduce or maintain SPS measures which result in a

higher level of sanitary or phytosanitary protection than would be achieved by measures based on the relevant international standards, guidelines or recommendations, if there is a scientific justification, or as a consequence of the ALOP in accordance with the relevant provisions of paragraphs 5.1 – 5.8 Notwithstanding the above, all measures which result in a level of sanitary or phytosanitary protection different from that which would be achieved by measures based on international standards, guidelines or recommendations shall not be inconsistent with any other provision of this Agreement.

* For the purposes of paragraph 3 of Article 3, there is a scientific justification if, on the basis of an examination and evaluation of available scientific information in conformity with the relevant provisions of this Agreement, a Member determines that the relevant international standards, guidelines or recommendations are not sufficient to achieve its appropriate level of sanitary or phytosanitary protection.

Standard-setting organizations

food safetyCODEX

plant healthIPPC

animal healthOIE

Codex = Joint FAO/WHO Codex Alimentarius CommissionOIE = World Organization for Animal HealthIPPC = International Plant Protection Convention (FAO)

HarmonizationArticle 3

EC Hormones – Article 3EC Hormones – Article 3

• Codex standards for 5 of 6 hormones• EC measure not based on Codex • “based on” requires some but not all

elements to be same• “conforms to” stricter requirement• Art. 3.3 is conditional right• To be consistent with Art. 3.3, must comply

with Art.5 (risk assessment)

Harmonization — Monitoring G/SPS/11/Rev.1 Harmonization — Monitoring G/SPS/11/Rev.1

• Aim of encouraging Members to use international standards

• Identifying where there is a major impact on trade resulting from the non-use of standards

• Help to understand when an international standard, guideline or recommendation is needed by:– Identifying the required international standard– Information from Members on their use or non-use of

the identified standards, guidelines or recommendations

New Notification ProceduresNew Notification Procedures

Recommendation to

notify all new or modified SPS measures, even when based on / conform to relevant international standards, guidelines or recommendations

G/SPS/7/Rev. 3 – takes effect 1 December 2008

procedures

– How long?– What methodology?– Whose science?– How determine if

“based on”?– Importer vs. Exporter

responsibilities

Members shall ensure that their SPS measures are based on

– an assessment, as appropriate, of the risks to human, animal or plant life or health,

– taking into account risk assessment techniques developed by the relevant international organizations.

Risk AssessmentArticle 5.1Risk AssessmentArticle 5.1

Risk Assessment – food safety

evaluation of the potential for adverse effects on human or animal health arising from the presence of additives, contaminants, toxins or disease-causing organisms in food, beverages or feedstuffs

Risk assessment – plant / animal health Risk assessment – plant / animal health

The evaluation of the likelihood of entry, establishment or spread of a pest or disease within the territory of an importing Member according to the sanitary or phytosanitary measures which might be applied, and of the associated potential biological and economic consequences.

EC Hormones – risk assessment EC Hormones – risk assessment

Measures not based on risk assessment (Art. 5.1)• “Based on” requires an objective and observable

relationship between the measure and the risk assessment

• Quantitative or qualitative risk assessment ok• Does not exclude factors that cannot be quantitatively

assessed • Risk assessments provided did not support prohibition

Measures not based on appropriate risk assessment (Art. 5.1)

• Identify the diseases which a Member wants to stop from entering

• Evaluate the probability of entry, establishment and dissemination in the case of diseases

• As a function of the SPS measures which could be applied.

Salmon – risk assessmentSalmon – risk assessment

Fire blight – risk assessment Fire blight – risk assessment

Measure not based on risk assessment

(Art. 5.1)• Risk assessment not specific to risk from

imports of mature apples • Did not take into account possible risk

mitigation measures

GMOs – risk assessmentGMOs – risk assessment

EC member State bans

• Not supported by EC risk assessment• Not based on new risk assessments - did not

evaluate likelihood of entry/ establishment / spread and potential consequences according to risk mitigation measures

procedures

– What ALOP?– How determine

consistency?– Evolving science– Evolving consumer

demands

ConsistencyArticle 5.5ConsistencyArticle 5.5

Members shall

avoid arbitrary distinctions

in appropriate level of SPS protection (ALOP) considered in different situations

if distinctions result in discrimination or disguised restrictions on trade

Hormones – Article 5.5Hormones – Article 5.5

“Consistency” is objective, not obligation

3 requirements for violation of Article 5.5

● Different levels of protection in different (but comparable) situations

● Different levels are arbitrary or unjustified

● Differences result in discrimination or disguised restriction to trade

Hormones – Article 5.5Hormones – Article 5.5

Different treatment for:

• administered natural hormones for growth promotion compared to those occurring endogenously in meat and other foods

• synthetic hormones for growth promotion compared to natural hormones occurring endogenously in meat and other foods

• hormones used for growth-promotion purposes and carbadox (anti-microbial growth-promoter used as a feed additive in swine production)

Salmon – Article 5.5Salmon – Article 5.5

No consistency in level of risk accepted (Art. 5.5)

Permitted importation of other products capable of transmitting some of the same diseases –

e.g., live bait fish, live ornamental fish

Consistency – Committee Guidelines(G/SPS/15)Consistency – Committee Guidelines(G/SPS/15)

• Two parts: • A) Appropriate level of sanitary or phytosanitary

protection (ALOP) • B) SPS Measures

• Principal points:• Clear identification of the level of protection• Compare the level of protection / measure with

• Previous decisions• International standards / other countries

• Transparency and communication between agencies

• Each Member should make public its ALOP

• A Member should compare the levels of protection achieved by different measures, to avoid arbitrary or unjustified differences

• Each authority that applies ALOP should be informed of the national policy on level of protection

• Each competent authority should be informed of activities of other authorities

Consistency – guidelines (G/SPS/15)

Consistency – guidelinesConsistency – guidelines(G/SPS/15)

• Have common objectives and/or consistent procedures for evaluating measures that can be applied to achieve the ALOP

• If the ALOP changes, existing measures should be reviewed to ensure consistency

• Existing measures should be revised regularly and modified if necessary to meet existing ALOP

procedures

– What ALOP?– How determine trade

effects?– How determine

feasibility?– Whose feasibility?

Without prejudice to paragraph 2 of Article 3, when establishing or maintaining sanitary or phytosanitary measures to achieve the appropriate level of sanitary or phytosanitary protection, Members shall ensure that such measures are not more trade-restrictive than required to achieve ALOP, taking into account technical and economic feasibility.

* … a measure is not more trade-restrictive than required unless there is another measure, reasonably available taking into account technical and economic feasibility, that achieves the ALOP and is significantly less restrictive to trade.

Salmon 21.5 – Article 5.6Salmon 21.5 – Article 5.6Salmon 21.5 – Article 5.6Salmon 21.5 – Article 5.6

“Consumer ready” requirement – packages of less than 450 g.

• More trade restrictive than necessary

(Art. 5.6)

Fire blight – Article 5.6Fire blight – Article 5.6 Fire blight – Article 5.6Fire blight – Article 5.6

More trade restrictive than necessary (Art. 5.6)

proposed alternative SPS measure - requiring that only mature, symptomless apples be exported - was

• reasonably available; • achieved Japan's ALOP; and • significantly less restrictive to trade

procedures

– What ALOP?– How determine?– How long?– Who does what?

What is « equivalence »?What is « equivalence »?

Article 4

Members shall accept the sanitary and phytosanitary measures of other Members as equivalent, even if these measures differ from

their own or from those used by other Members trading in the same product, if the exporting

Member objectively demonstrates to the importing Member that its measures achieve the importing Member’s appropriate level of sanitary

and phytosanitary protection

What is « equivalence »?What is « equivalence »?

• Legal terms - Article 4

• In practice – ?

Equivalence – in practiceEquivalence – in practice

• How determine if another measure / process / product is equally safe?

– Is aging equivalent to pasteurization re: cheese safety?

– Can cold treatment replace fumigation?– Can vaccination ensure disease freedom?

• What is the ALOP (acceptable risk level)?

Equivalence – Committee Guidelines (G/SPS/19/Rev.2)Equivalence – Committee Guidelines (G/SPS/19/Rev.2)

• Can be requested for individual measures / products or whole systems

• Importing country should identify risks and explain its ALOP

• Importing country should provide its risk assessment or technical justification for its own measure

• Respond to requests within 6 months

Equivalence – Committee Guidelines (G/SPS/19/Rev.2)Equivalence – Committee Guidelines (G/SPS/19/Rev.2)

• Take into account current history of trade• Provide technical assistance to developing

countries who request recognition of equivalence

• Notify SPS Committee when equivalence is recognized

• SPS Committee to follow recognition agreements, bilateral arrangements

• Encourage Codex, OIE and IPPC to develop guidelines for equivalence

Equivalence - NotificationsEquivalence - Notifications

Two notifications so far:

• Dominican Republic – USA

• Panama – United States

procedures

– How define?– How determine?– How long?– Who does what?

Regionalization Regionalization

• Adapt measures to a region– All or part of a country– All or part of several countries– Taking into account eradication and control

programmes

• Prevalence of pests of diseases– Pest / disease-free zonas or areas of low prevalence

• Exporter to provide evidence– Reasonable access for inspection by importer

Members shall ensure that their sanitary or phytosanitary measures are adapted to the SPS characteristics of the area - whether all of a country, part of a country, or all or parts of several countries - from which the product originated and to which the product is destined. In assessing the sanitary or phytosanitary characteristics of a region, Members shall take into account, inter alia, the level of prevalence of specific diseases or pests, the existence of eradication or control programmes, and appropriate criteria or guidelines which may be developed by the relevant international organizations.

Members shall, in particular, recognize the concepts of pest- or disease-free areas and areas of low pest or disease prevalence. Determination of such areas shall be based on factors such as geography, ecosystems, epidemiological surveillance, and the effectiveness of sanitary or phytosanitary controls.

Exporting Members claiming that areas within their territories are pest- or disease-free areas or areas of low pest or disease prevalence shall provide the necessary evidence thereof in order to objectively demonstrate to the importing Member that such areas are, and are likely to remain, pest- or disease-free areas or areas of low pest or disease prevalence, respectively. For this purpose, reasonable access shall be given, upon request, to the importing Member for inspection, testing and other relevant procedures.

Regionalization – SPS CommitteeRegionalization – SPS Committee

Guidelines adopted May 2008 - G/SPS/48

Objective of the guidelines:• Improve transparency, exchange of information,

predictability, confidence and credibility between Importing and Exporting Members

Guidelines:

I. General Considerations

II. Initial Discussions:• Clarify the process, required information,

calendar (if possible)

III. Typical Administrative Steps

IV. Expedited Procedure

V. Monitoring

Regionalization – SPS CommitteeRegionalization – SPS Committee

procedures

– How to notify?– How to manage

notifications?– How to benefit from

notifications?– Time frames

When to notify?

Emergency measures IMMEDIATELY!!

Regular measures

Allow 60 day comment period!!Allow 60 day comment period!!

When modifications are still possible(draft text)

New or modified regulation or adoption of final rules

+No existing international standard or

Different than the international standardeven if based on international standard

+Significant impact on trade(restricting or facilitating)

even if just for one Member

What to notify? -- Recommendations(G/SPS/7/Rev.3)

Addenda, Corrigenda and RevisionsAddenda, Corrigenda and Revisions

• Addendum – provide additional information or changes to an original notification

• Corrigendum – used to correct an error in an original notification

• Revision – replaces an existing notification

Addendum & corrigendum must be read in conjunction with the original notification

SPS or TBT elementsSPS or TBT elements

When a regulation contains both SPS or TBT elements.....

• Notify according to both SPS and TBT Agreements

• Indicate which parts fall under:– SPS (e.g., a food safety measure)– TBT (e.g., quality or compositional requirements

• TBT and SPS notifications similar in content and format

• Difference is primarily in coverage and objectives

What else to notify?

SPS Committee:• Recognition of equivalence• Recognition of pest- or disease-free status

– Measure recognized– Products affected

• Special and differential treatment G/SPS/33)– If an exporting developing Member has difficulties

with a notified measure

• Availability of informal translations

TranslationsTranslations

If they exist or are plannedIdentify them.

Send them.

Developed countries:

furnish documents or summaries in

WTO working language

Developed countries:

furnish documents or summaries in

WTO working language

Unofficial translationsUnofficial translations

Notifications circulated Notifications circulated

Members notifying since 1995 Members notifying since 1995

020406080

100120140160

DevelopedCountries

DevelopingCountries

Least-developedcountries

Not notified

Notified

SPS Notifications – Regional Breakdown (1995-2007)

Latin America and the Caribbean

Africa and the Middle East

Asia29%

Europe12%

North America34%

Publication of regulationsPublication of regulations

Publish what?Publish what?SPS regulationsSPS regulations

PromptlyPromptlyWhen?When?

allow a reasonable interval (6 months) before entry into

force(except in urgent

circumstances)

allow a reasonable interval (6 months) before entry into

force(except in urgent

circumstances)

Transparency timelineTransparency timeline

1. Drafting of the regulation

2. Publication of a notice

3. Notification to other Members

4. Draft text upon request (or website)

5. Receive & discuss comments

7. Adoption of the regulation

8. Publication of the regulation...

9. Entry into force of the regulationMin. 6 months

Min. 60 days

6. End of comment period

Replies / explanationsReplies / explanations

Enquiry point

Provides answers and documentation to all reasonable questions from interested Members– Government or independent– Can be same as NNA– Can have more than one but clearly

define responsibilities

All reasonable questions?All reasonable questions?

Regarding…• SPS regulations, draft or adopted• Inspection procedures, etc.• Risk assessment• Membership in international organizations or

international agreements• Text of these agreements

Making it workMaking it work

• Resources need not be extensive

• Existing infrastructure such as computer, photocopier, telephone, postal services, fax

• Additional resources such as email and internet

But more importantly

Using the Enquiry Point: Beyond Obligations

• Collect/disseminate SPS information– SPS documents

– SPS notifications received that could affect exports

• Inform other government agencies, private sector• Coordinate comments on other

countries’ notifications

Enquiry Point

Other government bureausPrivate sector

Geneva missionOIE, Codex, and IPPC

WTO Secretariat

procedures

– Who?– How much?– When?– What works?

Technical Assistance on SPS Agreement (1)

Article 9

Technical Assistance

“Members agree to facilitate provision of TA…”– help countries comply with SPS measures

• technology, research, infrastructure• advice, credits, donations, grants• technical expertise, training, equipment

– help countries maintain and expand market access

Technical Assistance on SPS Agreement (2)1994-2007Technical Assistance on SPS Agreement (2)1994-2007

National Seminars, 60 , 38%

(Sub) Regional

Workshops, 63 , 40%

Other, 32 , 20%

SPS Specialized Trade Policy Course, 3 , 2%

Standards and Trade Development Facility (STDF)

Strategic aimsStrategic aims

• Enhancing the expertise and capacity of developing countries to analyze and implement SPS standards.

• Acting as a vehicle for coordination in the provision and receipt of SPS-related technical cooperation.

Current OperationsCurrent Operations

• 14 donors • Total contributions to

date: US$16.2 million

• Medium Term Strategy 2007-11

• Annual funding target of US$5 million

For more informationFor more information

Standards and Trade Development Facility

World Trade Organization

Centre William Rappard

Rue de Lausanne 154

CH-1211 Geneva

Switzerland

STDFSecretariat@wto.org

www.standardsfacility.org

Workshop on Capacity Evaluation ToolsWorkshop on Capacity Evaluation Tools

March 2008• Information on various evaluation tools

– IPPC Phytosanitary Capacity Evaluation (PCE)– OIE Performance, Vision, Strategy (PCE)– FAO Biosecurity Tool

• Concern of duplication, costs• Need for coordination

(G/SPS/R/52)

Workshop on Good Practice in SPS-related Technical AssistanceWorkshop on Good Practice in SPS-related Technical Assistance

October 2008• STDF research on “successful” SPS projects in

Mekong Delta region, Central America, East Africa

• Paris Principles for technical assistance• Application to SPS area

Workshop on Good Practice in SPS-related Technical AssistanceWorkshop on Good Practice in SPS-related Technical Assistance

Suggestions for follow-up work focused on:

• increase awareness about Paris Principles and good practices in SPS-related technical assistance;

• develop a framework and indicators to assess impacts quickly and easily;

• case studies on how a value-chain approach has enhanced trade performance for particular commodities or consider cumulative effects of technical assistance in SPS area over time; and

• ongoing cooperation with EIF to ensure SPS issues integrated into national development plans and budgetary processes.

procedures

– What is reasonable?– How long?– How managed?

GMOs – Main conclusionsGMOs – Main conclusions

• Protection of biodiversity – under SPS• Food allergens – under SPS• SPS measure: approval procedure – but

existence of prior approval not challenged

Moratorium – found to exist -- application of measure – violation of Annex C

• No violation:

Art. 2.2, 2.3, 5.1, 5.5, 5.6, 7

GMOs – Main conclusionsGMOs – Main conclusions

Product Specific Measures• Panel examined 27 specific applications • Failure to complete individual approval

procedures without undue delay for 24 products• Violation: Article 8, Annex C (1) (a)• No violation: Articles 2.2, 2.3, 5.1, 5.5, 5.6, 7

GMOs – not consideredGMOs – not considered

• If biotech products pose risk to health or environment

• Right to have prior approval procedure• EC approval legislation• Conformity with Agreement on Technical

Barriers to Trade• If biotech products are “like” conventional

products

Challenges in implementing the SPS Agreement Gretchen Stanton Agriculture and Commodities Division.

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