current pesticide registration regulation peranan croplife ... · peranan croplife indonesia dalam...

Peranan CropLife Indonesia

Dalam Meminimalkan Pemalsuan Pestisida

Deddy DjuniadiExecutive Director CropLife Indonesia

19 Juni 2012

INDONESIA

Current Pesticide Registration RegulationIndonesia

Deddy Djuniadi Executive Director

Farm Chemical International Trade Summit – Jakarta 2012农药

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Representing the Plant Science Industry

Population : 241 mio

No. of island : 17.508 islands

No. of province : 33 province

No. of tribes : 247 tribes

Total area : 1.904.569 sq km

Agriculture area : 38.172.000 ha

No. of farmer : 39.33 mio (2011)

Main food : RICE

View of Indonesia

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• 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.

Agenda

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Relevant Rules and Regulation

Government Regulation No. 7/1973 :

• All pesticides which distributed, stored and commercializedin 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.

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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)

Regulatory Bodies

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• 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.

Regulatory Bodies

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Regulatory Bodies and Tasks

TE

Technical

Experts -

University

MOA

TE

MOF

MOH

AFDC

MOIMOTMOE

MOMF

IV

V

CPIS

Centre for

Permit &

Investment

MOA

- Ministry of Agriculture (MOA)

- Ministry of Forestry (MOF)

- Ministry of Health (MOH)

- Ministry of Trade (MOT)

Inter Ministerial- Agency for Food and Drugs Controlling (AFDC)

- Ministry of Environment (MOE)

- Ministry of Industry (MOI)

- Ministry of Marine and Fishery (MOMF)农药

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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

Registration Classification

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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.


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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.


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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 : ± 1500-7500 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

Type of Registration

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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.

Type of Registration

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Registration Process and Timeline

Accepted

Dossier screened by Pest Com secretary/CPIS

CPIS = Centre for Permit & Investment Services

Experiment permit (EUP)

Chemical analysis

Evaluated by CPIS

Sample sealed

Efficacy / toxicity test

By accredited laboratory

By Independent Institution / University /Government Research Institution

Evaluated by Expert Team of Pest Com

MOA Decree-Temporary permit-Permanent permit:re-new every 5 years

Registration 1.5 years

Pest Com-Plenary meeting

Approved

Approved

QUARTERLY

2 months

II

V

2 months

Reject/Pending →letter issued

Submit documents for registration

2 months

I

III

8 monthsDepend on crop or trial type

IV

4 months



1 month

I

II

4 months

III

2 months

Submit dossier for re-registration

Re-registr 7 mths农药

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Chemical analysis

Evaluated by CPIS

Sample sealed

Efficacy / toxicity test

By accredited laboratory

By Independent Institution / University/Government Research Institution

Evaluated by Expert Team of Pest Com

MOA Decree


Pest Com-Plenary meeting

5-8 monthsDepend on kind of

crop/type of trials

1 months

3-4 monthsApproved

Approved


I

II

III

IV

1-2 months

Label Extension Process and Timeline

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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:

- DT50 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 0.015 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

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1. 2,4,5-T (95-95-4)

2. 2,4,6-T (88-06-2)

3. Natrium 4-brom-2,5-diklorofenol (4824-78-6)

4. Aldikarb (116-06-3)

5. Aldrin (309-00-2)

6. 1,2-Dibromo-3-kloropropan/DBCP (96-12-8)

7. Cyhexatin (13121-70-5)

8. Dikoro difenil trikloroetan/DDT (50-29-3)

9. Dieldrin (60-57-1)

10. 2,3-Diklorofenol (576-24-9)

11. 2,4-Diklorofenol (120-83-2)

12. 2,5-Diklorofenol (583-78-8)

13. Dinoseb (88-85-7)

14. Ethyl p-nitrophenyl benzenethiophosponate/EPN (2104-64-5)

15. Endrin (106-93-4)

16. Endosulfan (115-29-7)

17. Etilen Bromida/EDB (72-20-8)

18. Formaldehyda (50-00-0)

19. Yellow phosphorus (7723-14-0)

20. Heptaklor (76-44-8)

21. Kaptalol (2425-06-1)

22. Klordan (57-74-9)

23. Klordimefon (19750-95-9)

24. Leptofos (21609-90-5)

25. Heksakloro Siklo Heksan/HCH

including Lindan (608-73-1)

26. Metoksiklor (72-43-5)

27. Mevinfos (26718-65-0)

28. Monosodium metam

arsonat/MSMA (2163-80-6)

29. Natrium klorat (7775-09-9)

30. Natrium tribomofenol

31. Metil paration (298-00-0)

32. Halogen fenol including Penta

Chloro Phenol/PCP & its salt (87-86-5)

33. Pesticide contains active ingredient

Salmonella

34. Senyawa arsen (1327-53-3)

35. Senyawa merkuri (10112-91-1; 7546-30-7; 7487-94-7; 21908-53-2)

36. Striknin (57-24-9)

37. Telodrin (297-78-9)

38. Toxophene (8001-35-2)

39. Mireks (2385-85-5)

40. Chlordecon (143-50-0)

41. Penta Chloro benzene (608-93-5)

42. Sulfuryl acid (7664-93-9)

a.i Banned for all uses of Pesticides

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For Household Pesticide

• Dichlorvos

• Chlorpyrifos

For Fishery

• Trichlorfon

a.i Banned

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No. Active Ingredient CAS Number Use Field

1. Alumunium phosphide 20859-73-8 Agriculture products storage

2. Magnesium phosphide 12057-74-8 Agriculture products storage

3. Methyl bromide 74-83-9 Quarantine & pre shipping

4. Paraquat dichloride 1910-42-5 Crop Protection

5. Zinc phosphide 1314-84-7 Crop Protection

6. Sulfuril floride 2699-79-8 Agriculture products storage

7. Diquat dibromide 2764-72-9 Crop Protection

a.i as Restricted Pesticide

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No. Chemical name CAS Number Use Field

1. Benzene 71-43-2 For all uses

2. Formaldehyde 50-00-0 For all uses

3. Methanol 67-56-1 For household pesticide

4. Toluen 108-88-3 For household pesticide

5. N-Methyl Pyrolidon 872-50-4 For household pesticide

6. Silica 14808-60-7 For all uses

7. Methylene Chloride 75-09-2 For all uses

8. Ethylene Oxide 75-21-8 For all uses

9. Sulfuryl acid 7669-93-9 For all uses

Raw Materials Banned in Pesticide Formulation

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No. Chemical name CAS Number Maximum Limit of Exposure

1. N-Methyl Pirolidon 872-50-4 600 ppm

2. Methanol 67-56-1 250 ppm

3. Piridine base 68391-11-7 5 ppm

Raw Materials Restricted for Crop Protection

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Peranan CropLife Indonesia

Dalam Meminimalkan Pemalsuan Pestisida

Deddy DjuniadiExecutive Director CropLife Indonesia

19 Juni 2012

INDONESIA

Thank You

Q & A

Deddy Djuniadi Executive Director

Farm Chemical International Trade Summit – Jakarta 2012农药

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current pesticide registration regulation peranan croplife ... · peranan croplife indonesia dalam...

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