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Sanitary and Phytosanitary Measures Agreements - Salient Features Ms Shashi Sareen, Director, Export Inspection Council, Ministry of Commerce & Industry.

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Presentation on theme: "Sanitary and Phytosanitary Measures Agreements - Salient Features Ms Shashi Sareen, Director, Export Inspection Council, Ministry of Commerce & Industry."— Presentation transcript:

1 Sanitary and Phytosanitary Measures Agreements - Salient Features Ms Shashi Sareen, Director, Export Inspection Council, Ministry of Commerce & Industry

2 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

3 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

4 Definition of an SPS measure To 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

5 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

6 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

7 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

8 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

9 Rights and Obligations Under The SPS Agreement

10 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

11 Key Provisions Scientific Justification Article 5 Harmonization Article 3 Equivalence Article 4 Disease-free areas Article 6 Technical assistance Article 9 Transparency Article 7

12 Scientific Justification of SPS Measures Measures conform to international standards (Article 3) Measures based on a risk assessment (Article 5 & 2)

13 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

14 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 exports review SPS measures based on more objective risk assessment within a reasonable period of time

15 Harmonization Article 3 Encourage use of international standards Food safetyAnimal 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

16 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…

17 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

18 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

19 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…

20 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

21 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

22 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 include Processing technologies Research & infrastructure Establishment of regulatory bodies Form of advice, credits, donations, grants, training, equipment Source - bilateral or through international organizations

23 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 foods SPS if related to food safety TBT if the regulation concerns issues such as; positioning, letter size, nutrient content, grade, etc. Contd…

24 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

25 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

26 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

27 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

28 Export Inspection Council: Role In WTO Environment

29 Export Quality Control – A 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 Act Notify commodities for compulsory PSI Specify standards for export and type of QC & I Establish or recognise Agencies for QC & I Nearly 1000 commodities notified

30 EIC Structure Apex Body – Council, Chairman, 18 members, Member Secretary- Director, EIC Specialist Committees EIC – The Organization CEO Director, office at Delhi Machinery for Export Certification – 5 EIAs at Mumbai, Kochi, Kolkata, Delhi and Chennai 41 Sub-offices & labs

31 Liberalization 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

32 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

33 EIC-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 EICs 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

34 EIC - Role In Wto Regime contd Training and technical assistance to industry to upgrade to International standards Represent Indias 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

35 International Recognitions EC - Designated CA for marine products & basmati rice; dialogue on for dairy products, egg products, poultry meat, honeyEC - Designated CA for marine products & basmati rice; dialogue on for dairy products, egg products, poultry meat, honey USA (USFDA) - recognized for Black Pepper – no detention if accompanied by EIC certificate; initiated dialogue for poultryUSA (USFDA) - recognized for Black Pepper – no detention if accompanied by EIC certificate; initiated dialogue for poultry Australia (AQIS) - recognized for marine products – maximum 5% random verification- seeking for dairy, spices, honey, etcAustralia (AQIS) - recognized for marine products – maximum 5% random verification- seeking for dairy, spices, honey, etc Sri Lanka (SLSI) - recognized for 85 regulated products (food, cement, engineering items, electrical appliances etc) Singapore – MRA in area of food & agri, electrical & electronics, drugs, telecommunicationSri Lanka (SLSI) - recognized for 85 regulated products (food, cement, engineering items, electrical appliances etc) Singapore – MRA in area of food & agri, electrical & electronics, drugs, telecommunication Turkey – recognized EIA health certificates for st steel & pkgTurkey – recognized EIA health certificates for st steel & pkg S.Korea (KFDA)- recognised for food and agri products.S.Korea (KFDA)- recognised for food and agri products. ItalyItaly Others - EU countries, Mexico, Nepal, Bangladesh, Libya, Japan.Others - EU countries, Mexico, Nepal, Bangladesh, Libya, Japan.

36 Products Covered Under Export Certification Products Covered Under Export Certification Nearly 1000 commodities notified in all sectors (Food, footwear, chemicals, engineering, leather, jute etc.) Under Mandatory Certification Fish & Fishery Products Dairy Products Egg Products Poultry Meat & Poultry Meat Products Honey Raw Meat (Frozen/chilled), Processed Meat

37 Systems Of Inspection & Certification Consignmentwise inspection Systems Approach In-Process Quality Control Self-Certification Approval and monitoring of processing and manufacturing units based on food safety management systems such as GMP/ GHP / HACCP.

38 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.

39 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

40 Status Of Approvals Units approved : Fish: EU – 144 (PP)+2(ZV)+11(CS), Non EU – 250 Dairy-41 Egg products – 4 Honey – 2 Poultry meat – 2

41 Role 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

42 Major Issues Of Concern

43 FAOs 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.

44 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

45 Transparency Members shall notify their sanitary or phytosanitary measures and shall provide information on these in accordance with laid down provisions No 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

46 Risk-based Approach Article 5 provides SPS measures to be based on risk assessment and if requested by exporting country make known details of assessment Some developed importing countries fixing standard without risk assessment – eg vibrio parahaemoliticus Inspite of repeated requests risk evaluation not made available

47 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 aspects Some countries stressing on infrastructural aspects eg milking machines, flake ice machines; primary production etc Concept of equivalence needs to be recognised

48 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 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)

49 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 country Brought back consignment shown absence of contamination Different methods of sampling & test – positive in one and negative in other lab Complete retesting of brought back consignments to rectify situation Destruction leads to wastage of national resources especially if contamination removed through reprocessing

50 Economic Impact Of Certain Measures Language barrier eg health certificates in Spanish- NTB Regulatory Measures eg milk products Voluntary Standards – ISO 9000/ ISO – 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

51 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

52 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 facilities Risk analysis studies Studies on economic impact of measures imposed Exchange of information and views

53 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

54 Thank you


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