Sanitary and Phytosanitary Measures Agreements Salient Features

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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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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

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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

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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

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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

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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

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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

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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

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Rights and Obligations Under The SPS Agreement
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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

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Key Provisions

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

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Scientific Justification of SPS Measures

• Measures conform to international standards
• (Article 3)

• Measures based on a risk assessment
• (Article 5 2)

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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, RD, residues, data

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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

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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

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Export Inspection Council Role In WTO
Environment
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Export Quality Control A Background

• Export (QCI) 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

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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

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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

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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

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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, FV,
  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 MoHFW

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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

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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.

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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

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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.

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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.

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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

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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

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Role Strengthening

• Modernizationautomation,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 (HRQDC)
• Interaction with Regulatory Authorities for
  equivalence agreements all FTAs to have role
  for EIC
• Technical Assistance - 8 projects with EC

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Major Issues Of Concern
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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.

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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

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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

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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

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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

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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)

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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

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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

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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

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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

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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

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Thank you