Food Safety: Global and Local Food Safety: eat local, think global Trade in food and agriculture products account for more than 10% of global trade Ta

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1 國際食品衛生安全規範 : WTO/SPS, Codex Kuei-Jung Ni Who decides what we eat? If people let government decide what foods they eat and what medicines they take, their bodies will soon be in as sorry a state as are the souls of those who live under tyranny Thomas Jefferson ( ) 國立交通大學科技法律學院倪貴榮老師 1

2 Food Safety: Global and Local Food Safety: eat local, think global Trade in food and agriculture products account for more than 10% of global trade Taiwan relies on food from US, Japan, China etc. Regulating imported food may constitute trade barriers Food safety standards on int l basis are increasingly demanding and increasing. WTO 國立交通大學科技法律學院倪貴榮老師 2

3 Established in members WTO 95% of global trade regulated by WTO Trade: goods, services and intellectual property Taiwan joined WTO in 2002 as 144 th member under the name of TPKM (Chinese Taipei) Trade in goods: WTO/SPS GATT 1994: tariff, quota, rule of origins Non-tariff barriers (NTB): technical barriers to trade (TBT) and Sanitary and Phyto-sanitary Measures (SPS) TBT and SPS 國立交通大學科技法律學院倪貴榮老師 3

4 SPS Agreement Food safety, animal, plant and human health Balancing trade liberalization and national health law and policy (FDA, Department of Agriculture and Diseases Control (CDC)) Trade in food Disputes: GMOs, Animal Drugs in food animals (hormones, ractopamine), fruits (apples) Art. 1: SPS Measures Annex A, definition: para.1. The objectives and purposes of applying SPS measure: (a) to (d) -- subject to be protected; and risks to be prevented The contents of SPS measures: Very broad, inspection, certification Also including: packaging and labeling requirements directly related to food safety Cf TBT labeling Q Which agreement or both should govern GMOs labeling? 國立交通大學科技法律學院倪貴榮老師 4

5 GMOs labeling GMOs labeling 國立交通大學科技法律學院倪貴榮老師 5

6 Art. 2: Basic rights and obligations Incorporate and elaborate GATT principles 2.1 National right to adopt SPS measures 2.2 Subject to necessity requirement, based on scientific principles and evidence ( general cf. 5.1;5.2 specific) 2.3 GATT Arts. I, IV, XX, chapeau 嚴格科學主義 (sound science base) 由管制者負舉證責任 (not safe) Art. 2: Basic rights and obligations 2.4 If measures are SPS-legal, presumed to be consistent with GATT 1994, particularly, Art. XX (b). Dealing with the overlap of competence between GATT & SPS. 國立交通大學科技法律學院倪貴榮老師 6

7 Art. 3: Harmonization Separation of Powers: WTO not making standards (trade and economic profession), referring to other standard-setting org. WTO gave these int l standards certain authority by incorporating them into SPS(TBT) Harmonization 調和 as one of devices to minimize impact caused by national SPS measures Int l standards: from voluntary nature to enforceable character International standards, guidelines and recommendations Competent organizations: Annex A, 3.: Three Sisters Food safety: Codex Alimentarious Commission (Codex); Animal health and zoonoses: International Office of Epizootics; Plant health: International Plant Protection Convention (IPPC) 國立交通大學科技法律學院倪貴榮老師 7

8 Codex Art. 3: Harmonization Definition: Annex A, 2. What members should do as International standards are available? Carrot and Stick: Three tracks (choices) Based on international standards whenever possible; 國立交通大學科技法律學院倪貴榮老師 8

9 International standards For matters not covered by the above orgs, Art. 3: Harmonization Conformity Benefits: deemed ( 視為 ) necessary; presumed to be ( 推定 ) consistent with SPS & GATT 1994: Presumption of consistency: Can be rebuttable, but hard to undertake cf TBT s harmonization (Art. 2.5), SPS provides a bigger carrot? 國立交通大學科技法律學院倪貴榮老師 9

10 Case 2012, Codex stand on ractopamine: 10ppb If Taiwan adopts 10ppb, it s up to complainant to rebut. Save political, economic and legal costs. Art. 3: Harmonization: Scientific Justification Deviation from international standards The adoption of a more stringent or lower of SPS is permitted on the condition that a scientific justification is met or comply with risk assessment provided in Art. 5. AB (Hormones): is the right of members, not an exception to 3.1(based on), but this conditional (heavy to fulfill) Cf TBT, put more burden on importing country Q: What the effect and significance of science? Always reliable? May vary according to new findings? 國立交通大學科技法律學院倪貴榮老師 10

11 Codex 的成立 國際食品安全委員會 (Codex Alimentarious Commission) was created in 1963 by FAO and WHO, HQ: Rome Development of international standards for food safety, to promote health and fair trade of food products: food additives, veterinary drug and pesticide residues, contaminants, methods of analysis and sampling, and codes and guidelines of hygienic practice Codex 標準制定 The initial status of Codex s standards: voluntarily, non-binding on Members (FAO, WHO) Science basis and risk analysis The proposals drafted by members Risk assessment: JECFA, peer review of data submitted by industry. Experts not reflect global representation. 國立交通大學科技法律學院倪貴榮老師 11

12 Codex 標準制定 Standards proposed used to be adopted by consensus, rarely by voting. Increasingly difficult to reach consensus given the uncertainty of science on the safety of foods that involving modern biotechnology, Hormones, GMOs The process could be length, ineffective, subject to more political influence than professions Codex 標準制定 WTO s recognition of Codex standards push for resorting to voting. 國立交通大學科技法律學院倪貴榮老師 12

13 Article review Kuei-Jung Ni ( ), Does Science Speak Clearly and Fairly in Trade and Food Safety Disputes? The Search for an Optimal Response of WTO Adjudication to Problematic International Standard-Making, Food and Drug Law Journal, Vol. 68(1), pp The accountability of international standards Codex: standards setting is always formed on a fair and equitable basis? Doubt on Decision-making process. Ex. Not by consensus, but voting, sometimes, very narrow majority; MRL (Hormones) in Meat: 33 favor, 29 against, 7 abstentions Hormones beef: the EU approach not adopted during Codex deliberations, GMOs: guidelines on bio-tech products 2012 July Ractopamine: 69 vs 67 國立交通大學科技法律學院倪貴榮老師 13

14 The accountability of international standards Mineral waters must be bottled at its origins: reflect EU view. The accountability of international standards Can Panel or AB conduct judicial review on the legitimacy of a Codex standard-setting Substantial or Procedural review? Procedural review: due process of law EC-Sardines might did it (almost) (but AB said no consensus required) US-Shrimp: US s lacking due process cannot justify the Chapeau of Art. XX of the GATT 1994 國立交通大學科技法律學院倪貴榮老師 14

15 The accountability of international standards The legitimacy for such review? No hierarchy in international legal systems (WTO and Codex are equal bodies of int l system) Amending SPS, TBT to provide review basis Elevating TBT s decision into Ministerial Conference or General Council s decision (authoritative interpretation) Art. 4: Equivalence Mutual recognition of SPS Taiwan s practice 國立交通大學科技法律學院倪貴榮老師 15

16 Art. 5: Assessment of Risk Framework of risk analysis, control and governance : risk assessment, risk management and risk communication, SPS/art. 5: except risk assessment, no explicitly mention risk management and communication Why WTO matters? Trade and health Food, medicines and medical devices are traded products, and involving services and intellectual property. 國立交通大學科技法律學院倪貴榮老師 16

17 Why WTO matters? WTO agreements relating to health -- Trade in Goods: GATT 1994, SPS, TBT(Non-tariff barriers to trade) -- Trade in services: GATS (medical services) -- Intellectual Property: TRIPS (patent on pharmaceuticals: patent linkage, undisclosed information) WTO matters Can trade liberalization reconcile with health protection (domestic food safety policy and law)? It s up to WTO to decide if we may eat US beef or pork? 國立交通大學科技法律學院倪貴榮老師 17

18 What s risk? Defining risk: cf damage laboratory risk vs real life risk Definition of a risk assessment: SPS, Annex A, 4 Cf RA on food safety or disease (animal or plant) Evaluation of the likelihood: probability, either quantity or quality; ascertainable risk Evaluation of potential Multifaceted of risk assessment risk manager food producers -- risk assessor --- consumers 國立交通大學科技法律學院倪貴榮老師 18

19 The work of risk assessment RA: -- evaluate scientific data, -- identify the hazard, -- decide potential (probability) harm to health: high or negligible Standard of Review How the Panel reviews the RA conducted by countries imposing SPS measures, two approaches: - deference - de novo DSU: Art.11, objective assessment of the facts 國立交通大學科技法律學院倪貴榮老師 19

20 Assessment of Risk Art. 5.1: Based upon risk assessments, taking into account risk assessment techniques developed by the relevant international organization. Based on: case-by-case basis; the case law remains abstract, left to diverse interpretation Assessment of Risk The role of the Panel; how and to what extend a Panel should do on national risk assessment? US/Canada Continued Suspension Should assess whether the reasoning articulated on the basis of the scientific evidence is objective and coherent... Should review whether the particular conclusions drawn by the Member assessing the risk find sufficient support in the scientific evidence relied upon Emphasize both reasoning and conclusions; must have justified relations between them 國立交通大學科技法律學院倪貴榮老師 20

21 Setting ALP Appropriate level of protection: subject to type of risks, Zero to acceptable risk: no-gmo, no animal drugs residual; maximum residual level(mrl) Assessment of Risk Art. 5.2: Factors taken into account Art. 5.3: Add economic consideration: 國立交通大學科技法律學院倪貴榮老師 21

22 Art. 5: Assessment of Risk Art. 5.4: should avoid negative trade effect Art. 5.5: (Art. 2.3) shall avoid arbitrary or unjustified distinctions Shall develop guidelines of practical implementation with SPS committee Art. 5: Assessment of Risk Art. 5.6: proportionality and necessity (necessity: reasonably available test), Art. 2.2 Art. 5.7: Insufficient scientific evidence: provisionally measures are allowed. (an indication of precautionary principle?) Art. 5.8: obligation to respond by a member applying the measures not considered consistent with int l standards or no existence of such standards. 國立交通大學科技法律學院倪貴榮老師 22

23 Art. 5.7 : insufficient scientific evidence WTO case law: Japan- Agriculture; Apples; EC-Tariff Preference; GMOs Article 5.7 should be viewed as a qualified exemption ( not exception) from the relevant obligation in Article 2.2, which confirms the right of Members to enact measures where the available scientific evidence is insufficient. Burden of proof on the complaining party, not member applying the measure, to demonstrate the inconsistency. How to decide scientific evidence is sufficient or not? insufficient scientific evidence (In)sufficiency of science is fixed? Or may change in light of the evolving nature of science Whether the level of protection set by imposing countries will affect the determination of sufficiency of scientific evidence? EC-Hormones II 國立交通大學科技法律學院倪貴榮老師 23

24 Art. 5: Assessment of Risk: Overview How do you evaluate Art. 5? The device is too burdensome for country using SPS measures which levels higher than int l ones? scientific justification plus free trade consideration Reform on Risk Assessment How to fix it if you think Art. 5 appears not balanced. 國立交通大學科技法律學院倪貴榮老師 24

25 USA Food, Drug and Cosmetic Act 2011 Food Safety Modernization Act (FSMA) From post-control (crises management) to prevention Strengthen inspections Risk-based Import control 國立交通大學科技法律學院倪貴榮老師 25