Eliminating Regulatory Differences Would Enhance Food Safety and Reduce Food Wastage Paul B Young, PhD Dubai Internation

1. Eliminating Regulatory Differences Would Enhance Food Safety and Reduce Food Wastage Paul B Young, PhD Dubai International Food Safety Conference Dubai, 24th February 2009 Waters Corporation paul_young@waters.com

2. Food Scares – A new phenomena? • The term “Food Scare” first appeared in the media in 1980s • One of the earliest recorded major food safety incidents involved ergotism (mycotoxins) which killed 44000 people in southern France in a single outbreak in 944 AD • Food safety has long held the potential to disrupt international trade:American German Pork Dispute : 1879 – 1891Disrupted $80M pork trade – ended when US authorities instituted an export certification scheme • What has changed is the volume of trade, the number of countries involved, our ability to detect issues and the technical complexity of the detection systems

3. Global value of food exports

4. US Maize exports – Global distribution • 5 Billion USD of maize exported annually

5. Chinese tea exports – Global Distribution • 500 Million USD of tea exported annually

6. Global trade in food increasing Many countries are actively pursuing the expansion of export markets. This is reflected in the declining US trade balance US exports to “high income” markets are declining. Now shifting towards developing markets (China and Mexico currently account for >25% of exports)

7. Food Trade is Truly Global • Viet Nam - > $3.5 billion of aquaculture exports annually • Processing capacity & demand both outstrip supply – Many processing plants operating at < 50 % capacity • Currently imports aquaculture products from 40 countries including India (26 per cent), China (18 per cent), ASEAN countries (18 per cent) and Japan (11 per cent) • Plans to grow imports by ~ 10% per annum until 2020

8. World Trade Organisation Agreements • Article 20 of the General Agreement on Tariffs and Trade (GATT)allows governments to act on trade in order to protect human, animal or plant life or health, provided they do not discriminate or use this as disguised protectionism. • Sanitary and Phytosanitary Measures Agreement (SPS) allows countries to set their own standards.Regulations must be based on science, but “precautionary principle” may be applied. • The Technical Barriers to Trade Agreement (TBT) tries to ensure that regulations, standards, testing and certification procedures do not create unnecessary obstacles.It encourages countries to recognize each other’s procedures for assessing whether a product conforms. Often equates to demands for EQUIVALENCE

9. THE CODEX ALIMENTARIUS Objectives • Established in 1963 by WHO/FAO • To protect the health of consumers • To ensure fair practices in the food trade • To promote coordination of all food standards work undertaken by international governmental and non-governmental organizations

10. THE CODEX ALIMENTARIUS • Codex guidelines generally used as the basis for food safety standards • Drugs without ADI not addressed by Codex • Codex standards still evolving • Countries are developing independent legislation referring to Codex where applicable

11. Consumer concerns in EU European Commission Special Eurobarometer 238

12. Consumer concerns in Japan In a Japanese survey around 70 % of consumers rated food safety as the most important issue By contrast, only 8 % thought price was the major concern

13. Japan Food Safety legislation • Japan is one of the least self-sufficient developed countries in the world, importing more than 60 % of its food • In 2002, the domestic consumer organization identified that high concentrations of some agricultural chemicals were found in some imported crops • Many of these agricultural chemicals found in imported crops were unauthorized for use in Japan • The response to non-compliance was not consistent - Every non-compliance was dealt with on a case-by-case basis

14. Europe Food Safety Regulation: European Food Safety Authority • EFSA – Independent scientific point of reference for risk analysis • Ensures scientific basis for food law • Establishes the Rapid Alert System for Food and Feed (RASFF) • Requirement for traceability for all stages of production

15. Japanese response • Establishment of Food Safety Commission • Revision for food and food additive standards to create “Positive List System” of 799 substances which must be controlled in all imported foodstuffs • Standards established with reference to Codex, EU or a “uniform limit” where necessary

16. Japan Food Safety legislationThe ‘Positive List’ System • Came into force on 29th May 2006 • Prohibits the distribution of foods that contain agricultural chemicals above a certain level if maximum residue limits (MRLs) have not been established in Japan • Mandates testing of imported foods for: Pesticides, veterinary drugs, harmful organisms • Applies to all food destined for the Japanese market • Importer typically require certification testing to the levels set out in the legislation to ensure product not rejected on entry to Japan

17. Japan Food Safety legislationThe ‘Positive List’ System • Compounds come under four categories, covered by: • Exempted substances • Provisional MRLs • The ‘Uniform Limit’ • Not detected (ND)

18. Japan Food Safety legislationUniform Limit • Uniform Limit (0.01ppm) • Applicable to agricultural chemicals where MRLs are not established. • Exceptions: when the Uniform Limit is not applicable even though MRLs are not established: • (i) Not Detected (ND) • Chemicals for which the ADI (Acceptable Daily Intake) established by the Japanese government is extremely low, instead of using the uniform limit, ND is reported. These compounds must not be detected in food. • (ii) LOD (Limits of Detection) of analytical methods • When LOD for analytical methods used by the Japanese local governments >0.01ppm i.e. when Uniform Limit cannot be achieved

19. EU Demands equivalent assurances from 3rd countries wishing to export • EU Maintains lists of establishments in each 3rd country which are approved to export a given commodity • Approval is subject to submission of acceptable control programmes • Programme implementation is verified by regular monitoring inspection visits (DG-SANCO Food and Veterinary Office) • Provision made to extend this to all food commodities under Council Regulation 882/2004

20. How do Japanese authorities ensure import food safety • Japan does not demand equivalence with control procedures • Japan does not operate prior-approval lists (except spinach)"The lesson from our success with improving the safety of spinach is that direct control of producers is the best method for quality control"Kazuhiko Tsurumi, Deputy Director, Import Food Safety Office, Ministry of Health, Japan. • Regulations place onus on importer to ensure imported food is compliant with rigorous standards • Compliance is ensured through very high level of import testing (laboratory tests > 10 % of imports)

21. Consequences of violation • Details of violations published quarterly • At first import, products must be subject to voluntary tests • Violations result in inspection orders – increased testing • Repeat violation may result in a ban on importation • In practice, importers demand test certificates from exporters

22. Where no tolerance exists Commission Decision2002/657 MRPL ~ required method sensitivity (<1.0 µg/kg for nitrofuran antibiotics) Essentially: non-compliance ~ any confirmed concentration

23. Substances with no ADI • Nitrofurazone • Member of the nitrofuran family: No ADI – No toleranceMRPL = 1.0 ppb • Beginning in 2002 nitrofurans caused major disruptions in international trade

24. Implementation of standards • RASFF Notification No. 2003/BBG, dated 15.05.2003:Pooled Frozen Soft Shell Crab taken from three consignments800 kg 200 kg1500 kg • SEM detected @ 0.7 µg/kg (residue of nitrofurazone) • Products were rejected and destroyed • 2.5 Tonne Soft shelled crab destroyed

25. When is a tolerance not a tolerance? Detection of residues below the MRPL is not of immediate concern MRPL should be employed as a reference point for action 0.7 µg/kg SEM no longer deemed non-compliant

26. Melamine in infant formula • September 2008 – Melamine identified in infant formula in China6 infants died300,000 infant sickened • Permitted concentration in infant formula Tolerance 1.0 ppm unless cyanuric acid also present

27. What standards do exporting countries apply? • In practice they often produce commodities for specific markets (Export Only Schemes) • India: Export certification – positive release scheme for grapes • Determine which EU countries product is suitable for – Prior to Harmonization within Europe! • Different schemes operate for export to Japan and US

28. EU Pesticide MRLs - January 2008 Sept. 2008 EU harmonized MRL adopted @ 1.0 mg/kg

29. Conclusions • Food trade is truly global • Countries are interdependent – Trade is more bi-lateral than is often acknowledged • Whilst export only schemes may be an effective means of ensuring trade, they are inefficient • International collaboration on safety standards and acceptance of methods of control will ensure safety, facilitate trade and simultaneously reduce wastage