Sanitary and Phytosanitary Measures Agreements -

Salient Features

Ms Shashi Sareen, Director, Export Inspection Council, Ministry of Commerce & Industry

Agreement On The Application Of Sanitary & Phytosanitary Measures

(SPS)

• Negotiated in parallel with major agricultural trade negotiations

• Came into force in 1995

• Applies to all measures used to protect human, animal and plant life and health which may directly or indirectly affect trade

SPS Agreement – A carefully crafted balance

• Rights

Members have the right to apply sanitary & phytosanitary measures necessary for the protection of human, animal & plant life or health (Article 2.1)

• Obligations

Members shall ensure that any sanitary or phytosanitary measure is applied only to the extent necessary for the protection of human, animal & plant life or health (Article 2.2)

Science provides the balance

Definition of an SPS measureTo Protect

Human or animal life or health

Human life or health

Animal or plant life or health

A country

From Risks arising from additives,

contaminants, toxins or disease causing organisms in their food, beverage, feedstuffs

Plant or animal carried diseases

Pest diseases or disease-causing organisms

Damage caused by the entry, establishment or spread of pests

Important Footnote

• “Animal” includes wild fauna and fish

• “Plants” include forest and wild flora

• “Parasites” include weeds

• “Contaminants” include pesticide residues, veterinary drug residues and extraneous matter

Types of Measures

End product criteria Process & production

methods Testing Sampling Inspection Certification &

approval procedures

Risk assessment methods

Quarantine treatments related to transportation of animals or plants

Packaging & labelling requirements related to food safety

Other Types of Measures

• Protection of the environment

• Consumer interests other than health

• Animal welfare

Not Covered by SPS Agreement but may be TBT Measures

Objectives of the SPS Agreement

• To protect and improve the current human health, animal health and phytosanitary situation of all Member countries

• To protect Members from arbitrary or unjustifiable discrimination due to different sanitary and phytosanitary standards

• To maintain the sovereign right of any Govt. to provide an appropriate level of protection ie allow countries to set their own standards for health and safety

Rights and Obligations Under The SPS Agreement

SPS Agreement –Basic Rights & Obligations (Article 2)

• Right to apply sanitary & phytosanitary measures necessary for the protection of human, animal & plant life or health

• Measures based on scientific principles

• Non-discriminatory

• No disguised restrictions on trade

Key Provisions

Scientific Justification Article 5

Harmonization Article 3Equivalence Article 4Disease-free areas Article 6Technical assistance Article 9Transparency Article 7

Scientific Justification of SPS Measures

Measures conform to international

standards

(Article 3)

Measures based on a risk

assessment(Article 5 & 2)

Risk Assessment Article 5• Covers assessment of risk & determination of

appropriate level of SPS protection• SPS measures to be based on

assessment of risks to human, animal or plant life or health, taking into account risk assessment techniques developed by international organizations.

available scientific evidences; process and production methods; inspection & sampling methods; prevalence of specified disease or pests; existence of pests/disease-free areas,etc

relevant economic factors & cost effectiveness of alternate approaches

• Avoid arbitrary/unjustifiable distinctions in the levels in different situations if these result in disguised restrictions

Precaution Article 5.7• Right:

To take provisional measures in case of insufficient scientific evidence

• Obligation:Can seek explanation of reasons for SPS measures

if constraining exportsreview SPS measures based on more objective risk

assessment within a reasonable period of time

Harmonization Article 3• Encourage use of international standards

Food safety Animal health Plant health

Codex OIE IPPC• SPS measures conforming to international

standards, are presumed to be consistent with SPS Agreement

• Right to impose more stringent requirements if based on scientific justification or risk assessment

Disease free areas Article 6

• Adaptation of SPS measures to regional conditions, including pest- or disease- free areas, differing climatic conditions & different pest or diseases or food safety conditions so as to lead to the development/imposition of different SPS requirements

• Exporter to demonstrate (reasonable access to be given for inspection/testing)

Contd…

Equivalence Article 4 Accept other members’ SPS measure as equivalent,

even if different from their own Exporting member must objectively demonstrates to

the importing member that its measures achieve their appropriate level of SPS protection – “equivalence” not “sameness”

Importing member to be given reasonable access for inspection/ testing

Equivalence Agreements - Members shall upon request, enter into consultation with the aim of achieving bilateral or multilateral agreements or recognition of the equivalence of specified SPS measures

Equivalence Agreements - Purpose

• Conformance to import requirements

• Avoid duplication – use collective resources more effectively & efficiently

• Provide mechanism for cooperative exchange of expertise, assistance & information to meet requirements

Transparency -Notification obligations Article 7

• Members are required to notify all sanitary and phytosanitary regulations which are adopted or proposed to be adopted

• Notifications made in the event of non-existence of an international standard or where substantially different from it or where there is a significant effect on trade

• Provisions also exist for emergency notifications when urgent problems of health protection arise

Contd…

Transparency –Notifications Contd

• Made through the National Notification Authority to the SPS/TBT Committee

• ‘Enquiry Points’ to be notified by each Member to disseminate information about existing and proposed SPS regulations, control and inspection procedures, quarantine treatment etc./ TBT standards, technical regulations & CA procedures

• Provision of ‘Emergency Notification’• Notifications as per prescribed format

Special and Differential Treatment

Article 10• Take account special needs of developing

countries when developing SPS measures • Allow longer time frames for compliance with

measures for products of special interest to developing countries

• Specific & time-limited exceptions on request to comply with Agreement

• Facilitate developing country participation in international organizations

Technical assistance Article 9

• Aim is to adjust to & comply with SPS measures to comply with SPS requirements of importing country & expand market access opportunities

• Areas includeProcessing technologiesResearch & infrastructureEstablishment of regulatory bodies

• Form of advice, credits, donations, grants, training, equipment

• Source - bilateral or through international organizations

Difference Between SPS &TBT

• Regulation regarding fertilisers

SPS if relating to residues in food or animal feed (objective protection of human/ animal health)

TBT if related to quality or efficacy of the product or health risk to handlers

• Labelling requirements for foodsSPS if related to food safety

TBT if the regulation concerns issues such as; positioning, letter size, nutrient content, grade, etc.

Contd…

Difference Between SPS &TBT

• Regulation regarding containers for the shipment of grains

SPS if relating to fumigation or other treatment of these containers,

i.e., disinfection in order to prevent the spread of disease

TBT if the regulation regards the size or structure of the containers

Problems In Implementation

• Participation in international standardising bodies

• Non representativeness of international standards

• Plethora of standardising bodies at the national and sub-national levels & lack of role clarity

• Absence of a national notification system • A general lack of awareness• Some aspects not very well developed –

traceability, risk assessment, R&D, residues, data

Main Government Agencies

• Directorate General of Health Services - PFA (1955)• Export Inspection Council - Export Inspection &

Quality Control Act • Bureau of Indian Standards - Food & Agriculture

Department• Department of Animal Husbandry & Directorate of

Plant Protection, Ministry of Agriculture, Dairying & Fisheries

• Ministry of Food Processing Industries - Food Products Order 1955, Integrated Food Law

Nodal Ministry • Ministry of Commerce (Trade Policy Division)

• Enquiry Points

SPS - Plant Protection Division (Deptt. of Agri. & Coop.), Ministry Of Health, Ministry of Commerce

TBT - Bureau of Indian Standards

Export Inspection Council: Role In WTO Environment

Export Quality Control – Export Quality Control – A BackgroundA Background

• Export (QC&I) Act, 1963 – umbrella Act governing quality of exports

• EIC set up to advise Government on measures for sound development of exports through QC & I to include notification of standards & certification systems

• Powers of Central Government under the ActNotify commodities for compulsory PSISpecify standards for export and type of QC & I Establish or recognise Agencies for QC & I

• Nearly 1000 commodities notified

EIC StructureEIC Structure• Apex Body – Council, Chairman, 18 members,

Member Secretary- Director, EIC

• Specialist Committees

• EIC – The OrganizationCEO Director, office at DelhiMachinery for Export Certification – 5 EIAs at

Mumbai, Kochi, Kolkata, Delhi and Chennai41 Sub-offices & labs

LiberalizationLiberalization

• Economic reforms early nineties

• Exemption from compulsory PSI for Trading / Star Trading Houses, EOUs, units in EPZs, Exporters with letter from foreign buyer not requiring official inspection

• Impact - All certification voluntary

• with establishment of WTO in 1995 export certification became important - change in focus

Implications • Increased Relevance of International Standards• Need to harmonize – avoid duplication & multiplicity –

ROLE CLARITY• Countries implementing strong import controls (USA,

EC, Canada, Australia, Japan etc)• Conformance to Int/ importing country requirements• Provision for recognition of export control &

certification systems as equivalent• Equivalence Agreements – MoUs/MRAs

Legislative framework Infrastructural facilities - Labs, inspection/certification bodies

• RENEWED RELEVANCE TO EXPORT CERTIFICATION OF EIC

EIC-Role In Wto RegimeEIC-Role In Wto Regime• Regulatory role to

address health & safety concerns of importing countries compulsory certification for Marine products, Egg products,

Milk products, Honey products, Poultry Meat products etc. • Voluntary export certification – Tea, F&V, Spices,

Basmati Rice• Equivalence Agreements/MOUs/MRAs with trading

partners for recognition of EIC’s certification• Certificate of Health (Food items), Authenticity

(Basmati Rice-EC)• Laboratory Testing

Support for Export Inspection & Certification Commercial testing (facilities extended to industry) Import testing of food items-EIA Labs identified by MoH&FW

EIC - Role In Wto Regime EIC - Role In Wto Regime contdcontd• Training and technical assistance to industry to upgrade

to International standards• Represent India’s interests in International standards

bodies/ WTO - views based on practical experience• Continuous dialogue with importing countries for

problem solving on non-tariff related issues• Problem oriented research – studies on issues related to

quality of Indian exports• Maintain information database on regulatory

requirements of trading partners• Issue of Certificates of Origin under various preferential

tariff schemes for duty concessions for exporters by foreign customs

• Participation in trade fairs

International Recognitions• ECEC - Designated CA for marine products & basmati rice; - Designated CA for marine products & basmati rice;

dialogue on for dairy products, egg products, poultry meat, honeydialogue on for dairy products, egg products, poultry meat, honey

• USA (USFDA)USA (USFDA) - recognized for Black Pepper – no detention if - recognized for Black Pepper – no detention if accompanied by EIC certificate; initiated dialogue for poultryaccompanied by EIC certificate; initiated dialogue for poultry

• Australia (AQIS)Australia (AQIS) - recognized for marine products – - recognized for marine products – maximum 5% random verification- seeking for dairy, spices, maximum 5% random verification- seeking for dairy, spices, honey, etc honey, etc

• Sri Lanka (SLSI)Sri Lanka (SLSI) - recognized for 85 regulated products - recognized for 85 regulated products (food, cement, engineering items, electrical appliances etc) (food, cement, engineering items, electrical appliances etc) SingaporeSingapore – MRA in area of food & agri, electrical & – MRA in area of food & agri, electrical & electronics, drugs, telecommunicationelectronics, drugs, telecommunication

• Turkey – Turkey – recognized EIA health certificates for st steel & pkgrecognized EIA health certificates for st steel & pkg

• S.Korea S.Korea (KFDA)(KFDA)- recognised for food and agri products.- recognised for food and agri products.

• ItalyItaly• OthersOthers - EU countries, Mexico, Nepal, Bangladesh, Libya, Japan. - EU countries, Mexico, Nepal, Bangladesh, Libya, Japan.

Products Covered Under Export Products Covered Under Export CertificationCertification

• Nearly 1000 commodities notified in all sectors (Food, footwear, chemicals, engineering, leather, jute etc.)

• Under Mandatory CertificationFish & Fishery ProductsDairy ProductsEgg ProductsPoultry Meat & Poultry Meat ProductsHoneyRaw Meat (Frozen/chilled), Processed Meat

Systems Of Inspection & Certification

• Consignmentwise inspection• Systems Approach

In-Process Quality Control Self-CertificationApproval and monitoring of processing

and manufacturing units based on food safety management systems such as GMP/ GHP / HACCP.

3-tier Surveillance System

• MONITORING BY EIA OFFICIALS TO VERIFY – Sanitation & Hygiene– Process controls– Implementation of HACCP plan– Records– Observe testing by laboratories– Draw samples of raw materials, water , ice, finished

products, swabs of workers hands and work places

• SUPERVISORY VISITS TO CHECK– Compliance to norms by processors– Quality and correctness of monitoring by EIA officers.

• CORPORATE AUDITS– Independent audit by EIC to verify operation of

scheme by EIAs as per documented systems.

Complaints Procedure• Complaints received• Unit placed on Alert ( inc monitoring; 10 consignments)• Investigation – visit to unit/information from processor• Satisfactory – ‘on alert’ continues• Unsatisfactory - consignments contaminated/ unsatisfactory hygienic conditions/ samples fail

– Prodn & export stopped till corrective actions taken– Show cause why approval not withdrawn

• Corrective actions taken and verified– Satisfactory ; resume production and exports– Officer deputed for10-30 days; 10 consignments tested – If unsatisfactory, then approval withdrawn

Status Of Approvals

• Units approved :Fish: EU – 144 (PP)+2(ZV)+11(CS),

Non EU – 250Dairy -41Egg products – 4Honey – 2Poultry meat – 2

Role StrengtheningRole Strengthening• Modernization–automation,computerization

(website) - transparency• Infrastructure especially lab buildings & equipment• Aligning inspection/testing to International stds- aim

of accreditation (ISO/IEC 17020/25,Guide 65• Streamlining activities in existing schemes• Study on Role of EIC in WTO environment• Empowering human resources (HR&QDC)• Interaction with Regulatory Authorities for

equivalence agreements – all FTAs to have role for EIC

• Technical Assistance - 8 projects with EC

Major Issues Of Concern

FAO’s Report On Implications For India Of SPS Agreement

There is a significant level of concern in India regarding the real or perceived replacement by some countries of tariff barriers to trade with sanitary & phytosanitary barriers and other technical barriers to trade. These concerns may be well founded based on the increased emphasis that is being placed on food safety & other SPS measures by many countries and the increased emphasis being placed on the inspection & control of imported food & agricultural products.

Harmonization • Members shall base their sanitary or

phytosanitary measures on international standards, guidelines or recommendations where they exist. Permits standards more stringent based on scientific justification

• However countries laying stringent standards-specifications (aflatoxin, v.cholerae)-test method (V.cholerae-Norway)

• Even within EU different standards & test methods

Transparency

• Members shall notify their sanitary or phytosanitary measures and shall provide information on these in accordance with laid down provisionsNo information on specification, methods of

sampling, inspection & test- chance to comment, familiarize (eg bacterial inhibitors, vibrio)

New regulations implemented without sufficient notice period

Regulations available in foreign language/complicated

• Leading to rejections

Risk-based Approach

• Article 5 provides SPS measures to be based on risk assessment and if requested by exporting country make known details of assessmentSome developed importing countries fixing

standard without risk assessment – eg vibrio parahaemoliticus

Inspite of repeated requests risk evaluation not made available

Safety Management Systems Approach

• Shift from CWI to Systems Approach-HACCP/9000

• Conrol systems which focus on preventive measures instead of relying on end-product testing for health & safety or quality aspectsSome countries stressing on infrastructural aspects eg

milking machines, flake ice machines; primary production etc

• Concept of equivalence needs to be recognised

Equivalence Agreements• Purpose

Conformance to import requirementsAvoid duplication – use collective resources more

effectively & efficientlyProvide mechanism for cooperative exchange of

expertise, assistance & information to meet requirements

• Cover - exchange of information on standards, recognition of certification, provision for retest and appeal, return of rejected consignments

• Problems- need: admin burden – control - income - important components not addressed - (SLSI, Canada, USA)

Rejection & Destruction Of Consignments

• Destruction of contaminated consignments – Guidelines for exchange of information on rejection of imported foods – provide all detail

• Unilateral decision - need to consult exporting countryBrought back consignment shown absence of contaminationDifferent methods of sampling & test – positive in one and

negative in other labComplete retesting of brought back consignments to rectify

situationDestruction leads to wastage of national resources especially

if contamination removed through reprocessing

Economic Impact Of Certain Measures

• Language barrier eg health certificates in Spanish- NTB• Regulatory Measures eg milk products• Voluntary Standards – ISO 9000/ ISO 14000 – restricts

market access till country upgrades, also cost of impln• SA 8000 Social Accountability – deals with working

conditions, better Q of life, other socioeco issues – importing country limiting imports

• Rapid Alert System – No systematic approach- hundreds of consignments – over 2 years

• Turtle extruder device• CE Marking – Absence of designated CA Bodies in

India – cost increasing due to foreign certifn & testing

Conformity Assessment Issues

• Test methods varying from international standards high sensitivity – based on capability not risk (eg

chloramphenicol, aflatoxin) non-validated (Norway – Vibrio cholerae)

• Different standards in different labs

• Results in increase in rejections

• Solution – joint testing, acceptance of certification of exporting country & not retesting

Points To Resolve Trade Issues

• Play strong role in international standardization & harmonize standards

• Seek technical assistance in a big way• Take up concerns with overseas governments/at various

international fora• Have Equivalence Agreements with major trade partners• Have regional cooperation and joint activities in

Databases on requirements – transalation facilitiesRisk analysis studiesStudies on economic impact of measures imposedExchange of information and views

Capacity Building

• Both Agreements provide for extending technical assistance to developing country members to enable them to comply with requirements of importing countries

• Some important areas include upgrading test facilities, empowering human resources, developing training modules establishing databases on importing country requirements

• Assistance coming too late or inadequate

Thank you