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: Obligation:
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 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

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
*SMS Approach – Codex, SLDBs, Utilisation & promotion of QA,
In India – BIS, PFA, EIC Primary production
*Harmonisation with Codex - SPS Agreement – countries impose stds –based on Codex/risk assessment
Codex vision statement – promote int stds for domestic & int trade
Situation in India -> 10 org – compulsory/ voluntary – harmonise what? – each org
*Ppn in stds formulation – SPS Agreement, earlier status of Codex & now benchmark
unsatisfactory – industry/ continuity/ right person
*Equivalence - SPS/ Codex – EIC
*Sound Regulatory framework – guidelines for design, operation, assessment & accreditation of food imp & exp
inspn & certifn systems
- legn, control progs & operations (inspn, sampling, test,hyg, records, verifn, audits)
- Frequency & intensity
- facilities, eqpt, transport, comm
- labs. - personnel
Capacity Bldg – strengthening regulatory framework
– upgrading test facilities
- empowering HR
-databases
-devt of modules haccp

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 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

34. EIC - Role In Wto Regime contd
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

35. International Recognitions
EC - 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 poultry
Australia (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, telecommunication
Turkey – recognized EIA health certificates for st steel & pkg
S.Korea (KFDA)- recognised for food and agri products.
Italy
Others - EU countries, Mexico, Nepal, Bangladesh, Libya, Japan.

36. 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. 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.

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