View of Indonesia Population No. of island No. of province No. of tribes : 241 mio : islands : 33 province : 247 tribes Total area :

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1 Current Pesticide Registration Regulation Peranan CropLife Indonesia Dalam Meminimalkan Indonesia Pemalsuan Pestisida Deddy Djuniadi Executive Director Deddy Djuniadi Executive Director CropLife Indonesia Farm Chemical International Trade Summit Jakarta Juni 2012

2 View of Indonesia Population No. of island No. of province No. of tribes : 241 mio : islands : 33 province : 247 tribes Total area : sq km Agriculture area : ha No. of farmer : mio (2011) Main food : RICE

3 Agenda Relevant Rules and Regulation Regulatory Bodies Registration Classification Type of Registration Registration Process and Timeline Label Extension Process and Timeline Data Requirement for Registration List of Prohibited & Restricted Use Pesticides Draft-New Regulation.

4 Relevant Rules and Regulation Government Regulation No. 7/1973 : All pesticides which distributed, stored and commercialized in Indonesia have to be registered and permitted from MoA. MoA Decree, No. 07/Permentan/SR.140/2/2007 : Guidelines and Requirement for Pesticide Registration. MoA Decree, No. 517/Kpts/TP.270/9/2001 : Pesticide Monitoring. MoA Decree, No 319/Kpts/OT.160/5/2006 : Pesticide Committee.

5 Regulatory Bodies Pesticide Committee : Under Department of Agriculture Inter Departments : Ministry of Agriculture (MOA) Ministry of Marine and Fishery (MOMF) Ministry of Forestry (MOF) Ministry of Health (MOH) Agency for Food and Drugs Control (AFDC) Ministry of Environment (MOE) Ministry of Trade (MOT) Ministry of Industry (MOI)

6 Regulatory Bodies Technical Expert of Pesticide Committee : Toxicology from Gadjah Mada University Efficacy/Entomology from Bogor Agriculture University Efficacy/Phytophatology from Bogor Agriculture University Efficacy/Weed Science from SEAMEO BIOTROP Chemistry from Indonesia Institute for Sciences Public Hygiene from Indonesia University Environment from Bandung Technology Institute Vector Control from Department of Health.

7 Regulatory Bodies and Tasks CPIS Centre for Permit & Investment MOA TE Technical Experts - University IV MOMF TE - Ministry of Agriculture (MOA) - Ministry of Forestry (MOF) - Ministry of Health (MOH) - Ministry of Trade (MOT) MOF MOE MOH MOT AFDC MOI V MOA Inter Ministerial - Agency for Food and Drugs Controlling (AFDC) - Ministry of Environment (MOE) - Ministry of Industry (MOI) - Ministry of Marine and Fishery (MOMF)

8 Registration Classification The Use of Pesticide are covering : Crop Protection Animal Husbandry & Animal Health Fishery Forestry Agricultural Product Storage Household Pesticides need additional permit from DOH for local free sales/distribution. Vector Control Quarantine and Pre-Shipping Transportation

9 Registration Classification A. Based on its physical chemical properties and toxicity : 1. Pesticide which can be registered. 2. Prohibited pesticide. Pesticide formulation within class IA or IB of WHO classification. LC50 inhalation of pesticide formulation less than 0.05 mg/l within 4 hours of exposure. Active ingredient or other ingredient indicates carcinogenicity (category I and IIA IARC classification), oncogenicity, teratogenicity and mutagenicity. B. Based on its application : 1. General use pesticide. 2. Restricted used pesticide. Need special requirement & safety equipment to apply. The applicator must well trained and hold certificate of being appropriate applicator.

10 Registration Classification Restricted Use Pesticides Applied if : Pesticide formulation corrosives to eyes which mean causing irreversible damage to the ocular tissue or irritate cornea up to 7 days or more. Pesticide formulation corrosives to skin or cause severe irritation up to 72 hours or more. When used in accordance with the label directions and commonly recognized practice, the pesticide may cause significant toxicity either sub chronic, chronic or delay effect to human. That can destroy the ozone surface Notes : The status of restricted use pesticides might be modified to either general use or even prohibited one by law based on suggestion or recommendation given by Pesticide Committee and its risk analysis.

11 Type of Registration A. Experimental Use Permit (EUP) EUP is required to run the trials in collaboration with appointed research institutes to obtain technical data (efficacy/toxicity) for registration purpose. Not allowed to make business activity (trading, promotion, etc). Granted for 1 year period, might be extended up to 2 times. Registration fee for EUP : ± 200 USD Registration fee for trial : ± USD (depend on crop) B. Temporary Permit Permit granted to those who have insufficient data/information derived from efficacy or toxicity trials. Allowed to make business activity at limited based. The permanent permit can be granted if entire requirement are completed. Granted for 1 year period, might be extended up to 3 times. Registration fee : ± 600 USD

12 Type of Registration C. Permanent Permit Permit granted to those who have submitted complete data/information (meet requirement for registration). Can be extended to add target/crop. Allowed to sell, distribute & store the products at no limit based. Granted for 5 years period, can be renewal every 5 years. Approval of renewal will follow existing criteria & regulation. Registration Fee : ± 600 USD Permanent permit can be reviewed/revoked if its proven to have a negative impact to the humans health and environment.

13 Registration Process and Timeline Submit documents for registration Dossier screened by Pest Com secretary/cpis CPIS = Centre for Permit & Investment Services Experiment permit (EUP) Reject/Pending letter issued Accepted I 2 months Submit dossier for re-registration Chemical analysis By accredited laboratory II I Evaluated by CPIS Sample sealed Efficacy / toxicity test Evaluated by Expert Team of Pest Com Approved Pest Com-Plenary meeting Approved MOA Decree QUARTERLY By Independent Institution / University / Government Research Institution -Temporary permit -Permanent permit: re-new every 5 years Reject/Pending letter issued Reject/Pending letter issued 2 months III 8 months Depend on crop or trial type IV 4 months V 2 months Registration 1.5 years 1 month II 4 months III 2 months Re-registr 7 mths

14 Label Extension Process and Timeline Chemical analysis Evaluated by CPIS Sample sealed Efficacy / toxicity test Evaluated by Expert Team of Pest Com Approved Pest Com-Plenary meeting Approved MOA Decree By accredited laboratory By Independent Institution / University/ Government Research Institution Reject/Pending letter issued Reject/Pending letter issued I 1 months II 5-8 months Depend on kind of crop/type of trials III 3-4 months IV 1-2 months

15 Data Requirement for Registration 1. Mammalian toxicity - Acute Toxicity for formulation (six tox packages) - Sub-chronic toxicity (3 months) on rat - Chronic toxicity : carcinogenic, teratogenic, mutagenic & oncogenic 2. Physical and chemical properties of formulation and active ingredients 3. Ecotox and environment data: - DT 50 in soil and water - Acute tox: bird, fish, honey bee, earth worm (micro-soil organism), aquatic organism (water flea, algae) - Local fish tox study for pesticide register in irrigation rice (carp and tilapia) 4. Residue data: If ADI to human mg/kg/day (equivalence 1 ppm) 5. Bio Efficacy Trial - Bio efficacy trial: 1 unit - Synergism laboratory trial for mixture formulation - Re-registration every 10 years, conducted in 1 crop against 1 pest 6. Does not induce resurgence of BPH for insecticide in rice 7. Does not have negative impact on the parasitoid of brassica s pest : Diadegma semiclausum and Cotesia plutellae 8. Does not have negative impact on the larva parasitoid s Spodoptera litura

16 a.i Banned for all uses of Pesticides 1. 2,4,5-T ( ) 2. 2,4,6-T ( ) 3. Natrium 4-brom-2,5-diklorofenol ( ) 4. Aldikarb ( ) 5. Aldrin ( ) 6. 1,2-Dibromo-3-kloropropan/DBCP ( ) 7. Cyhexatin ( ) 8. Dikoro difenil trikloroetan/ddt ( ) 9. Dieldrin ( ) 10. 2,3-Diklorofenol ( ) 11. 2,4-Diklorofenol ( ) 12. 2,5-Diklorofenol ( ) 13. Dinoseb ( ) 14. Ethyl p-nitrophenyl benzenethiophosponate/epn ( ) 15. Endrin ( ) 16. Endosulfan ( ) 17. Etilen Bromida/EDB ( ) 18. Formaldehyda ( ) 19. Yellow phosphorus ( ) 20. Heptaklor ( ) 21. Kaptalol ( ) 22. Klordan ( ) 23. Klordimefon ( ) 24. Leptofos ( ) 25. Heksakloro Siklo Heksan/HCH including Lindan ( ) 26. Metoksiklor ( ) 27. Mevinfos ( ) 28. Monosodium metam arsonat/msma ( ) 29. Natrium klorat ( ) 30. Natrium tribomofenol 31. Metil paration ( ) 32. Halogen fenol including Penta Chloro Phenol/PCP & its salt ( ) 33. Pesticide contains active ingredient Salmonella 34. Senyawa arsen ( ) 35. Senyawa merkuri ( ; ; ; ) 36. Striknin ( ) 37. Telodrin ( ) 38. Toxophene ( ) 39. Mireks ( ) 40. Chlordecon ( ) 41. Penta Chloro benzene ( ) 42. Sulfuryl acid ( )

17 a.i Banned For Household Pesticide Dichlorvos Chlorpyrifos For Fishery Trichlorfon

18 a.i as Restricted Pesticide No. Active Ingredient CAS Number Use Field 1. Alumunium phosphide Agriculture products storage 2. Magnesium phosphide Agriculture products storage 3. Methyl bromide Quarantine & pre shipping 4. Paraquat dichloride Crop Protection 5. Zinc phosphide Crop Protection 6. Sulfuril floride Agriculture products storage 7. Diquat dibromide Crop Protection

19 Raw Materials Banned in Pesticide Formulation No. Chemical name CAS Number Use Field 1. Benzene For all uses 2. Formaldehyde For all uses 3. Methanol For household pesticide 4. Toluen For household pesticide 5. N-Methyl Pyrolidon For household pesticide 6. Silica For all uses 7. Methylene Chloride For all uses 8. Ethylene Oxide For all uses 9. Sulfuryl acid For all uses

20 Raw Materials Restricted for Crop Protection No. Chemical name CAS Number Maximum Limit of Exposure 1. N-Methyl Pirolidon ppm 2. Methanol ppm 3. Piridine base ppm

21 Thank You Peranan CropLife Indonesia Dalam Meminimalkan Pemalsuan Pestisida Q & A Deddy Djuniadi Executive Director Deddy Djuniadi Executive Director CropLife Indonesia Farm Chemical International Trade Summit Jakarta Juni 2012