FAO IGG Intersessional Meeting Report on Tea MRLs

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Working Group on MRLs in Tea was formed to address pesticide residue issues affecting global tea trade. This report covers initiatives, data generation, and harmonization efforts from 2005 to 2015, leading to changes in MRLs for various pesticides. Recommendations for achieving global cooperation on tea MRLs were also discussed in the 20th Session of the IGG on Tea.

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INTERSESSIONAL MEETING OF FAO IGG ON TEA, MILAN, ITAY, 15 - 16 OCTOBER 2015 REPORT OF THE WORKING GROUP ON MRL IN TEA (NOV 2014 TO SEPT 2015) CHAIR: INDIA CO-CHAIR : UK MEMBERS: CANDA, ARGENTINA DR A K BAROOAH & MS KATIE DONNELLY JOINT COORDINATORS, WG ON MRL

Background The Working Group (WG) on MRLs in Tea was constituted in the Bali Meeting of the FAO-IGG on Tea in 2005 to assist data generation and submission as required for fixation of MRLs of pesticides in tea. Pesticide residues in tea has been a major non-tariff trade barrier affecting tea trade globally. A roadmap was prepared to work on 24 pesticides selected the on basis of global use pattern in 2005 in the 1st WG meeting at Kolkata. The objective was to generate data for fixing Codex MRLs as well as to use the data for fixing national MRLs which may lead to harmonization. Since then Codex MRLs in tea were fixed for 17 pesticides and the work of this initiative contributed to this process. In 2008-2015, seven international MRLs for endosulfan (CAC and EPA), cypermethrin (CAC), bifenthrin (EPA) and indoxacarb (China, CAC and EU) have been regulated on the basis of data submitted by China and IGG.

China & IGG Group initiative lead to change of MRLs in 2008-2015 Pesticide Agency Initial MRLs (mg/kg) Original proposed MRLs (mg/kg) 0.01 0.01(EU suggestion) 0.01(EU suggestion) 0.01 not set 0.05 5 Modified MRLs (mg/kg) Year of adoption US EPA 30 10 2008 Endosulfan CAC 30 10 2010 Cypermethrin CAC 20 15 2012 Bifenthrin US EPA CAC EU China 5 5 5 5 5 2009 2014 2015 2015 not set 0.05 3 Indoxacarb

The data also served as the basis for national & international MRLs. Pesticides Paraquat Methidathion Clothianidin Fenpropathrin Chlorpyrifos Indoxacarb Propargite Deltamethrin Endosulfan Etoxazole Cypermethrin Hexythiazox Thiamethoxam Permethrin Bifenthrin Dicofol Flubendiamide CODEX MRL (mg/kg) EU MRL (mg/kg) 0.05* 0.1* 0.2 0.5 0.7 2 2 5 5 5 10 15 15 15 20 20 30 40 15 0.7 2 0.1* 5 0.05*# 5 30 15 0.5 4 20 0.1* 5 20 0.02* [http://www.codexalimentarius.net/pestres/data/commodities/details.html?id=101 ] *Lower limit of analytical determination, # effective 3.10.2015

In 20th Session of the IGG on Tea (Colombo, 30 Jan - 1 Feb 2012) Intergovernmental Action [Ref Doc:CCP 12/14 E, Feb 2012 ] The Group recommended that harmonization of tea MRLs be changed to "Achieve global cooperation obtaining MRLs in tea . Canada 1 MRL [ Propiconazole ] USA 8 MRLs [ Bifenthrin, Buprofezin, Clothianidin, Fenpropathrin, Fenpyroximate, Spiromesifen, Thiamethoxam & Tolfenpyrad] Australia 6 MRLs [Temporary MRLs for Diquat, Fluazifop-butyl, Glufosinate ammonium, Paraquat, Imidacloprid & Azoxystrobin ]

Identifying key issues to develop an action plan on priority list Number of compounds under trial Submission of data to JMPR Capacity building for residue analysis Cooperation in computation of dossiers Feedback was sought from members to update the status

In 21st Session of FAO-IGG on Tea at Bandung, held on 5-7 Nov 2014 1. Priority list prepared & updated with 61 pesticides Currently used compounds Replacements for older chemicals New pesticides with potential use in future 2. Data generation on residues in tea [China, India, Sri Lanka] 3. Data submission to Codex, national regulators 4. Scope of simultaneous submission for 10 other pesticides

Updates on the Priority List [Based on response from members] Submission to Codex, MRL (date) Data Availability No of trials & Country National MRLs [MRL (Country)] Pesticides 4(Japan) 4 (India) 8 (China) 6(Japan) 2(India) 1. Acetamiprid Yes 40 (Jp), 50 (US) 2. Bifenthrin 30 (2011) Yes 30 (Jp) , 30 (US) 30 (codex, Green Tea) 3. Buprofezin Submitted to EU 6(Japan) 30 (Jp), 20 (US) 2(Japan) 10 (China) 8 (Sri Lanka) 2(Japan) 2(Japan) 6 (India) 2(Japan) 3(Japan) 2 (India) 2(Japan) 4(India) 4. Chlorfenapyr Yes 0.01 (US), 40 (Jp) Not submitted 5.Chlorfluazuron Yes 10 (Jp), 6.Chlorpyrifos 2 (2005) Yes 10 (Jp), 7.Chromafenozide Limited 20 (Jp), 8.Clothianidin 0.7 (2011) Yes 50 (Jp), 70 (US) 9.Cypermethrin 15 (2012) Yes 20 (Jp)

Submission to Codex, MRL (date) Data Availability No of trials & Country National MRLs [MRL (Country)] Pesticides 10. Dimethoate 11. Emamectin Benzoate Limited 1 (Jp) 2(Japan) 2(India) 2(Japan) 2 (India) 2(Japan) 4 (India) In progress 0.5 (Jp) 12.Fenpropathrin Yes 2 (2007) 25 (Jp), 2 (US) 40 (Jp), 20 (US) 0.1 (Argentina) 13. Fenpyroximate Yes Not submitted 14. Fipronil Yes 8 (Sri Lanka) 0.002 (Jp) 2(Japan) 2 (India) 15.FlubendiamideYes 50 (2011) 50 (Jp) (8trials, 2014) 16. Flufenoxuron Yes 2(Japan) 15 (Jp) 2(Japan) 8 (Sri Lanka) 2 (India) 2(Japan) (8trials, 2015) 17.Imidacloprid Yes 10 (Jp) 18. Permethrin Limited 20 (Jp)

Submission to Codex, MRL (date) Data Availability No of trials & Country National MRLs [MRL (Country)] Pesticides 5 (Jp), 10 (US), 10 (India), 1 (Argentina) 30 (Jp), 40 (US), 60 (Canada) 2(Japan) 6 (India) 19. Propargite 5 (2004) Yes 20. Spiromesifen Yes 2(Japan) 4 (Japan) 2 (India) 8(Registrant) 4 (Japan) 4 (India) 2(Japan) 4 (India) 8(China) 21. Thiacloprid Yes 30 (Jp), 22.Thiamethoxam Yes 20 (Jp), 20 (US) 20 (2011) 23. -Cyhalothrin Yes 15 (Jp) 24. Indoxycarb 25. Dichorvos 5 (2013) Yes 0.1 (Jp) To be generated 26. Novaluron 27. Abamectin

Submission to Codex, MRL (date) Data Availability No of trials & Country National MRLs [MRL (Country)] Pesticides 0.5 (Argentina), 40 (Jp), 20 (Jp) 28. Acequinocyl In progress 4(Japan) 29. Chlofentezine 2(Japan) 50 (1997) Revoked, 40 (2011) 3(Jp), 5 (India) 50(US) 30. Dicofol Yes 8(India) 31. Ethion 32. Etoxazole 33. Hexythiazox Yes Yes Yes 12(India) 4(Japan) Registration for tea deleted (Jp) 0.3(Jp), 5 (India) 15 (Jp), 15 (US) 35 (Jp), 1 (Argentina) 15 (2012) Codex MRL [8 field trials conducted in India] 34. Milbemectin 35. Permethrin Limited Limited 2(Japan) 2(Japan) 0.7 (Jp) 20 (Jp)

Submission to Codex, MRL (date) Data Availability No of trials & Country National MRLs [MRL (Country)] Pesticides 36. Polysulphide sulphur 37. 2,4-D 38.Diuron Exempted Limited In progress 1 (India) Not Regd in Japan Not registered in Japan 2 (Japan) 1 (Jp) 39. Glufosinate- ammonium Limited 0.01 (India), 0.3 (Jp) 0.5 (Argentina), 1 (US) -- Leaf 7 (US) Powder 1 (Jp) 40. Glyphosate Yes 41. MCPA 42. Metolachlor Yes 8 (Sri Lanka) Not submitted

Submission to Codex, MRL (date) Data Availability No of trials & Country National MRLs [MRL (Country)] Pesticides 43. Oxyfluorfen Limited 1 (India) 8 (Japan) 2 (India) 4 (Japan) 0.2 (2006) 0.3 (Jp) 44. Paraquat Yes 10 (Jp), 20 (US) 45. Azoxystrobin 46. Bitertanol 47. Chlorothalonil Yes Yes Limited 8 (Sri Lanka) 0.1 (Jp) 2 (Japan) 2 (India), Not Required in Japan 8 (Sri Lanka) 4 (Japan) 2 (India) Not submitted 10 (Jp) 150 (India) as copper (ML), Exempted (Japan) 150 (India) as copper (ML), Exempted (US, Japan) Exempted (US, Japan) 10 (Jp) Joint Application with India Joint Application with India 48. Copper hydroxide Yes 49. Copper Oxychloride Yes 50. Copper oxide Yes 51. Difenoconazol Limited 2 (Japan)

Submission to Codex, MRL (date) Not submitted Data Availability No of trials & Country National MRLs [MRL (Country)] Pesticides 8 (Sri Lanka) 3 (India) 8 (Sri Lanka) 3 (India) 8 (Sri Lanka) 2 (Japan) 4 (Sri Lanka) 2 (Japan), 1 India 2 (Japan) 0.05 (Jp) 52 Hexaconazole Yes 0.1 (Jp), 4 (Canada) 5 (Jp) ? 53. Propiconazole Yes Not submitted 54. Pyroclostrobin Yes 50 (Jp) Not submitted In progress 55. Tebuconazole 56. Thiophanate- methyl 57. Trifloxystrobin Limited 58. Carboxim Limited 7 (Jp) Not submitted 3 (Japan) 5 (Jp) Not submitted Not submitted 30 (Codex, Green Tea) To be done 8 (China) 4 (Japan) 20 (Jp), 50 (US) 59. Tolfenpyrad Available

Scope of Global cooperation in obtaining MRLs in tea Aetamiprid: 8 trials data available [Scope for submission by Japan, India & China] Hexaconazole: 11 trials data available [Scope for submission by Sri Lanka & India] Propiconazole: 11 trials data available [Scope for submission by Sri Lanka & India] Chlorfluazuron: 10 trials data available [Scope for submission by Sri Lanka & Japan] Fipronil : 8 trials data available [Scope for submission by Sri Lanka] Imidacloprid: 12 trials data available [Scope for submission by India, Japan, & Sri Lanka, for Evaluation 2015)]

Scope of Global cooperation in obtaining MRLs in tea Flufenoxuron: 8 trials data [Evaluation 2014] MCPA: 8 trials data [Scope for submission by Sri Lanka] Ethion: 12 trials data [Scope for submission by India] Pyroclostrobin: 8 trial data [Scope for submission by Sri Lanka] -Cyhalothrin: 6 trials data available. Needs 2 more. Buprofezin: 6 trials data available. Needs 2 more. [The data submitted to EU did not meet the requirements for EU] Fenpyroximate: 4 trials data available, Needs 4 more.

Action plan (1) To assess status of field trials required for setting Codex MRLs & submission of the list for advance notification to FAO-IGG & National Codex Points. (2) To update priority list based on new information on Risk assessment, or Replacements or Potential use in Tea. (3) To assess status & development of required infrastructure & new methods to cope with changing situations & cost. (4) Communication plan for quick information exchange and advance notification for simultaneous data submission by members & seeking manufacturers support and to negate adverse publicity. (5) Data submission to include brew factor based risk assessment for all teas traded globally except Matcha Tea. (6) To share available information on anthraquinone and risk assessment in tea and tea brew.

Progress made since 21st Session at Bandung held on 5-7 Nov 2014 1. Codex Priority list updation for fixation of MRLs in Tea Ethion (2017), Profenophos (2017), Propiconazole, Hexaconazole (2017), L-Cyhalothrin (2017), Fenazaquin (2017), Acetamiprid (2017), Quinalphos (2017), Imidacloprid (2017),Tebuconazole (2017), Spiromesifen (2016, 2017), Dimethoate (2017), Carbendazim (2017), 2,4-D (2017), Bifenthrin (2017) [Request was made through Indian delegation to 47th Session CCPR, China in April 2015] Cyclaniliprole (2017), Pyraclostrobin (2017) and Pyrifluquinazon (2017). [The above 3 compounds were requested by the manufacturers]. CCPR accepted this request

2. Data generation for fixation of MRL in tea Multi-locational supervised field trials were carried out Oct-Dec (2014) & May to Aug (2015) in India to generate additional data on 17 pesticides Emamectin Benzoate, Flubendiamide, Imidacloprid, Acetamiprid, Propiconazole, Thiamethoxam, Dimethoate, Hexaconazole, Fenpyroximate, Mancozeb, Bifenthrin, Clothainidin, Fenpyroximate, Profenophos, Hexythiazox, Cypermethrin & L-Cyhalothrin in tea to close the data gap for fixation of national MRLs. The data as required will also be submitted through National Codex Point for JMPR evaluation.

Data generation work in China Supervised field trials as par Good Agricultural Practice (GAP) were carried out in China in 2014 on 12 pesticides, viz., tolfenpyrad, indoxacarb, propargite, pyraclostrobin, chlorfluazuron, propiconazole, thiacloprid, imidacloprid, thiamethoxam, acetamiprid, dimethoate and dinotefuran.

3. Data submission for MRL fixation Data on 9 pesticides (Bifenthrin, Clothinidin, Fenpropathrin, Fenpyroximate, Hexythiazox, Hexaconazole, Propiconazole, Thiamethoxam and Mancozeb) were submitted to FSSAI Food Safety Authority of India in June 2015 for revision/fixation of national MRLs in tea using brew factor for risk assessment.

Proposed MRL in Tea is calculated using the OECD MRL calculator Total number of data (n) Percentage of censored data Number of non-censored data Lowest residue Highest residue Median residue 7 Compound Thiamethoxam Crop Region / Country GAP 0% 7 0.030 2.110 0.570 0.919 0.961 1.000 Tea India 7 days Mean Standard deviation (SD) Correction factor for censoring (CF) Residues (mg/kg) 0.030 0.030 0.570 0.040 1.790 2.110 1.860 Proposed MRL estimate 2.110 - Highest residue - Mean + 4 SD - CF x 3 Mean Unrounded MRL Rounded MRL 4.761 2.756 4.761 5 High uncertainty of MRL estimate. [Small dataset]

Risk assessment carried out using the brew factor Computation of MRL for fenpyroximate in tea (*For an Indian adult of 50kg weight) (ADI : 0.01 mg/kg bw) Pestici de Highes t residu es (HR) (mg/k g) Food consum- ption (g) %of ADI per person based on HR %of ADI per person based on proposed MRL Proposed MRL (mg/kg) TMDI (mg/da y) based on HR TMDI (mg/da y) based on propose d MRL of 2 mg/kg ADI (mg/ kg/ day) *ADI (mg/ person / day) Fenpyr o- ximate 1.78 1.78 10 10 0.0178 0.0178 x 0.031* = 0.000552 0.04 0.04 x 0.031* = 0.00124 0.01 0.01 0.5 0.5 3.56 0.11 8.0 0.25 4.0 4.0 * [Brew Factor; Ref: Barooah et. al.,2011] The proposed MRL of 4 mg.kg for fenpyroximate in tea should not be of health concern as it amounts to 0.25 % of the toxicological ref point (ADI).

MRL fixation in tea in China China MRL mg/kg 0.1 5 10 5 0.05 20 15 1 20 0.2 0.05 10 5 0.2 10 20 10 0.05 15 5 0.5 EU MRL mg/kg 0.05* 5 0.05* 0.1* 0.05* 0.1* 1 0.1* 0.5 0.2* - 5 0.01* 20 0.05* 0.1 30 0.02* 10 2 0.05* Japan MRL mg/kg 10 30 30 10 0.2 30 15 20 20 0.2 - 10 20 3 15 20 30 - - 25 0.2 Pesticides Classification Acephate Bifenthrin Buprofezin Carbendazim Carbofuran Cartap L-cyhalothrin,cyhalothrin Cyfluthrin, beta-cyfluthrin Cypermethrin,beta-cypermethrin DDT Demeton Deltamethrin Diafenthiuron Dicofol Difenoconazole Diflubenzuron Endosulfan Ethoprophos Fenazaquin Fenpropathrin Fenitrothion Insecticide Insecticide Insecticide Fungicide Insecticide Insecticide Insecticide Insecticide Insecticide Insecticide Insecticide Insecticide Insecticide Insecticide Fungicide Insecticide Insecticide Insecticide Insecticide Insecticide Insecticide

Fenvalerate/ S-fenvalerate Flucythrinate Glufosinate-ammonium Glyphosate Hexachlorocyclohexane HCH) Hexythiazox Imidaclothiz Indoxacarb Isazofos Isocarbophos Methomyl Omethoate Permethrin Phosfolan Phoxim Pyridaben Terbufos *Indicates lower limit of analytical determination Insecticide 0.1 0.1* 1.0 Insecticide Herbicide Herbicide Insecticide Insecticide Insecticide Insecticide Insecticide Insecticide Insecticide Insecticide Insecticide Insecticide Insecticide Insecticide Insecticide 20 0.5 1 0.2 15 3 5 0.01 0.05 0.2 0.05 20 0.03 0.2 5 0.01 0.05* 0.1* 2 0.02* 4 0.01* 5 0.01* 0.01* 0.1* 0.05* 0.1 - 0.1 0.05* 0.01* 20 0.3 1 0.2 35 - - - - 20 1 20 - 0.1 10 -

4. Communication on change of status of standards Harmonization of National Standards with Codex & other International Standards Australia A submission has been made in Australia in Jan 2014 requesting adoption of the EU/Codex MRLs for thiacloprid, spiromesifen, clothianidin, etoxazole, hexythiazox, thiamethoxam & chlorfenapyr. India The Food Safety & Standard Authority of India (FSSAI) initiated harmonization of its standards with that of Codex through e-working groups in May 2013. The work is in progress. Kenya Adopted Codex MRLs in tea for 14 pesticides in Aug 2015

Kenya Introduced a Draft Standard KS 2128: 2015 in August 2015. Codex MRLs have been adopted for 14 compounds

Kenya Draft Standard KS 2128: 2015 List of pesticides and maximum residue limits for tea (Green tea/Black tea) Sl No. Pesticides Kenya Codex MRL (mg/kg) 0.2 0.5 0.7 MRL (mg/kg) 0.2 0.5 0.7 2 2 5 5 10 15 15 15 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. Paraquat Methidathion Clothianidin Fenpropathrin Chlorpyrifos Deltamethrin Propargite Endosulfan Etoxazole Hexythiazox Cypermethrins (including alpha- & zeta- cypermethrin) Permethrin Thiamethoxam Bifenthrin 2 2 5 5 10 15 15 15 12. 13. 14. 20 20 30 20 20 30

Action taken on Propargite [EU notification to WTO (Notification G/SPS/N/EU/72 : MRL 5mg/kg to 0.05 mg/kg] (1) Argentina, India & ETC sent communications to EU on the essentiality of propargite use in tea. (2) Manufacturer submitted dossier to EU on 2 June, 2014 (3) Additional data on xenotoxicity submitted in 2015 for review by EU. (4) India carried out a study on Propargite metabolites in tea in colla- boration with M/S Chemtura (USA) in Aug-Sep 2014. Residues in tea shoot, black tea and brew: Propargite, TBPC, HOMe-TBPC, HOMe-TBPC-diol, Carboxy-TBPC-diol & HOMe-TBPC glucoside (5) EU decision on fresh submission of data is expected by end 2016.

5. Update information on Anthraquinone in Tea Anthraquinone is a bird repellent. Not used in tea as a pesticide. Emerging as a major problem in tea [BfR opinion No. 005/2013, 12 Feb/2013 ] BfR removes anthraquinone from its list of recommendations for food packaging following EFSA opinion in 2012 Source of contamination in tea : Packaging material ??? During Tea Manufacturing process ??? In Tea plants ??? Through various Inputs ??? Ambient sources ???

In the last meeting it was decided to share information on anthraquinone as it was detected in many tea samples from a number of countries. A LC-MS/MS based test method for determination of anthraquinone in tea was developed at TLabs TRA, India in March 2015 with an LOQ of 0.02 mg/kg. The method was validated with a EU PT sample provided by EU-TIA (erstwhile ETC) Chair Dr Thomas Hann. The study on the sources is in progress. Simultaneous work on literature search showed ubiquitous presence of anthraquinone in the environment.

Anthraquinone in Tea [Tea Research Association, India and UK Tea & Infusion, Associtation Collaboration study initiated in Oct 2014] Representative MRM chromatograms for Anthraquinone & Anthraquinone-d8 (at 20 ng/mL concentrations, m/z 208, 216), GC-MS/MS

The WG on Tea Brew Chair: China, Co-chair(s), India, USA

Status of work undertaken Policy document entitled Guidance Document on Risk Assessment Using Brew Factor For Fixation of MRLs of Pesticides In Tea drafted jointly by India and China with comments from USA and Japan.

Title page GUIDANCE DOCUMENT ON RISK ASSESSMENT USING BREW FACTOR FOR FIXATION OF MRLS OF PESTICIDES IN TEA [Prepared By Indian and Chinese delegations, Working Groups on MRL and Tea Brew of FAO-IGG on Tea with comments from USA , Japan and Sri Lanka]

In continuation. The policy document entitled Guidance Document on Risk Assessment Using Brew Factor For Fixation of MRLs of Pesticides in Tea will be discussed and finalized for submission to the CCPR and JMPR for reference.

Future Action Plan (1) To assess status of field trials required for setting Codex MRLs & submission of the list for advance notification to FAO-IGG & National Codex Points. (2) To update priority list based on new information on Risk assessment, or Replacements or Potential use in Tea (3) To share information on consuming countries on MRL restrictions. (4) To assess status & development of required infrastructure & new methods to cope with changing situations & cost. (5) Communication plan for quick information exchange and advance notification for simultaneous data submission by members & seeking manufacturers support and to negate adverse publicity. (6) Data submission to include brew factor based risk assessment for all teas traded globally except Matcha Tea. (7) To share available information on anthraquinone, nicotine and other contaminants and to explore a global study for data.