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Indonesia

by Joeli Hartono Rianto

THE DEVELOPMENT OF PESTICIDES MANAGEMENT POLICY IN INDONESIA

Background and justification

Most developing countries as it is in Indonesia, pesticides have been using for more than four decades. Pesticides application has become one of the most important means in dealing with pest and disease control of either crops or any other fields such as household, quarantine, fishery, wood preservative, pre-shipment, stored products and so on. There are many more activities in the communities where pesticides are being applied for their own purposes.

When the use of pesticides was introduced at the first time, it was mostly intended to control pest on important crops like paddy and secondary crops. Unfortunately, no one was aware how its use would induce negative impacts to the environment as its use grew substantially. In addition, most farmers have not been well trained yet to handle pesticides properly, and consequently occupational death, environmental damage and severe injuries were hence, unavoidable.

No sufficient regulation existed as the use of pesticides began in the early sixties and there were no technical instruments as well as technical adviser available. Farmers learned how to use these products from their neighborhood and to some extent they asked field worker to make sure of the choice.

As most pesticides in Indonesia were applied for agricultural practices, the government of the Republic of Indonesia assigned the Minister of Agriculture to manage pesticides through the Government Stipulation No. 7 of 1973. Any pesticides intended for use and distribution in Indonesia should hold permission issued by the Minister of Agriculture or otherwise it is considered as illegal use and distribution.

Based on the above government stipulation, Minister of Agriculture then, has issued a number of decrees dealing with procedure on registration, requirement on label and packaging, limitation on registration, terminating of registration and so on. Those split policy was issued within different periods of time as it brings inconsistency when going through implementation. Hence, the government has to provide one comprehensive regulation at once to be the only powerful rule in serving people at better standard.

It was started in 2001 when the Minister of Agriculture issued the Ministry of Agricultural Decree No. 434.1 as so called De-regulation on pesticides registration. It was a spectacular decree as all previous decree of different aspects were compressed into one single package of regulation containing most recent technical requirement that are more or less international standard. Besides, such regulation opened more opportunity to any new player in pesticides business as far as all technical as well as administrative requirements are fulfilled. All registration documents should comply with standard data as issued by FAO/WHO or any other recognized institute specification. In addition, validity data have become imperative for evaluation. It means, not all data and information are accepted unless they are considered valid and be worthy of further evaluation.

To get along with the harmonization program on the pesticides registration, the government of Republic of Indonesia has kept trying to adopt standards (when applicable) issued by dedicated international institution such as FAO/WHO, US-EPA, OECD etc. Nowadays, any pesticide product that is registered in the country bears international standard as it was evaluated quite strictly when it applied for registration.

Pesticides application in Indonesia

From the perspective of crop management, the use of pesticides will be only the last alternative as the concept of IPM has been socialized as well as implemented to most Indonesian farmers, including those working on estate crops. Field schools were established at considerable number of the production center throughout the country. The implementation of IPM concept was successfully done except for those who are cultivating crops in the remote areas. There were hundreds thousands of farmers trained on IPM concept and farmer's understanding on such a concept was quite high.

Due to such a consideration, de-regulation on pesticides registration was issued on the base of IPM approach. Meanwhile, government has offered industry to apply for new registration for their products as it may create more products available in the market, hence it brings about more competition, empowering bargaining position of farmers, availability of good but affordable products, guarantee availability and so on. However, all marketed pesticide products are subject to review as they indicate negative evidence that harm people or environment when it is applied not complying with IPM concept.

Even more items are now available in the market, but in fact not all of them are really absorbed. It is going to be back on the market mechanism where the best and most competitive product can remain in the market to help farmers. Many of them seem not too attractive to use.

Pesticides may help increase the quality of agricultural products in many ways as its use quite large in quantity. Some pesticides have to be applied on the basis of interval application in case of preventing crop from suffering from a number of major diseases. Most horticultural products are considered as high-economic commodity that needs to be more protected from pest and diseases rather than any other agricultural commodity.

Meanwhile, pest and diseases problems on crops occur all the time at any time since crop are always there. Planting season all the year round obviously provide sufficient food for pest. This situation help promote threatening any cultivated crop from loss due to pests. Therefore, pesticides application may not be held from use what so ever.

Progress of registered product

Pesticides intended to register varies from household pesticides to Plant Growth Regulator (PGR). Among them, herbicide is the highest in number on registration following by insecticide, fungicide, rodenticide etc. Based on our statistical data by end of 2004 the total numbers of registered pesticides were some 1 281 products. The following Table shows total registration in 2002, 2003 and 2004.

Out of 1 281 products recorded in 2004, 209 were new registrations. New registrations have increased from year after year. Within the past three years the trend of new registration has grown at least 13 - 15 percent per annum. However, such a record is not available in the market since some of them are not ready to be launched. The average availability is about 45 - 60 percent of the total registered product.

Table 1. Progress of Registered Pesticides in the past 3 years

No.

Items

2002

2003

2004

1

Household Pesticides

221

274

184

2

Herbicides

201

282

298

3

Insecticides

201

469

421

4

Fungicides

133

197

179

5

Rodenticides

17

22

23

6

Acaricides

11

17

16

7

Bactericides

2

3

5

8

PGR

24

30

31

9

Nematicides

7

10

7

10

Molusicides

5

8

7

12

Repelent

1

1

20

13

Ajuvant

76

98

75

14

Others

2

3

15


TOTAL

901

1 414

1 281

As it may happen in every country, where insecticides remain sitting in the top rank of distribution as well as registration as compared to any other pesticides. The market share of insecticide is about 34 percent indicating more insect problem are faced as compared to diseases or weed or even any other organisms. The ecosystem of insect population has been severely disturbed as insecticides were applied excessively. Some major insect pests are known to be endemic pests in certain area such as Brown Plant Hopper, Stem Borer, Fruit Flies, cabbage worm, etc. Total active ingredients of insecticides being registered in Indonesia are some 94 (ninety four). Following insecticides, herbicide takes second position in popularity being applied from fully cultivated area to tidal-swamp area. In some extent, herbicides are applied to least soil tillage (TOT) and it really works well in some area in the country. There are now more than 70 (seventy) active ingredients of herbicides registered in Indonesia, some are known as contact action and some other are translocation (systemic action).

The application of herbicides is increasing in agricultural practices since its use offers less cost in land preparation, hand weeding, and soil tillage in some heavy areas. Farmers prefer to apply more herbicides to shortcut time budgeting in cultivation to reach the best time of harvesting and earning the best price of harvested product. Production cost may be reduced up to more than 40 percent by applying herbicides compare to those are not. It is proven to be quite tempting.

The application of fungicides is mostly being done in the horticulture production centers. Disease problem on cabbage, potatoes, onion, red chili, tomatoes, paprika and many other high valued commodities exist with no indication to decline unless being controlled by fungicides. As the area of horticultural is not as large as for food and secondary crops, the use of fungicides is a little less than the application of insecticides and herbicides. But the application of fungicides from the perspective of individual is quite a lot as it is applied on interval basis to prevent the disease occurrance. Nowadays, total active ingredients of fungicides registered are 61 (sixty one).

Other pesticides such as rodenticide, nematicides, bactericides, and so on are quite small in quantity. Its use is very limited and not very common by farmers and other users.

From the table it is shown that the numbers of registration are not always increasing. The number of registration of insecticides in 2003 was 469 and declined to be 421 in 2003 due to some withdrawals from registration and some were not evaluated any further. This illustration is always happen every single year. Thus, the total number recorded in 2004 is cumulated of the total number in registration.

De-regulation of pesticides registration not only promoted the number of registered products but also triggered the number of new registration holders. Prior to the enacting of de-regulation the total number of registration holders were 128. It increased substantially year after year and the total number of registration holders was recorded to be more than 430 holders. The following Table 2 shows in detail information on the development of registration holder during the past three years.

Table 2. Development of Registration Holders within three years (2002 - 2004)

No.

Items

2002

2003

2004

1

Household pesticides

69

71

72

2

Herbicides

88

97

114

3

Insecticides

65

114

94

4

Fungicides

51

53

66

5

Rodenticides

15

14

15

6

Acaricides

9

13

13

7

Bactericides

4

3

3

8

PGR

16

18

20

9

Ajuvants

34

37

23

10

Nematicides

6

5

5

11

Molus

3

4

5

12

Others

15

5

5


TOTAL

375

434

435

It shows a significant increase of the total number of registration holders as compared to the number before de-regulation was officially issued by end of 2001. The major reason for this situation to occur was that there were no longer limitations in registration as it was formerly applied by rule. De-regulation was officially opened up for newcomers, new products and diversifying the scope of work of business players. Some of new registration holders were pesticide distributors or retailers. In addition, some new players also never dealt with pesticides business until de-regulation made it possible to do so. Hence, these days, the players vary from those who are quite professional to any other who are really new in doing pesticides business. Therefore strong supervision and control to its distribution has become important and is being paid more attention by the government to restrain counterfeit and vague products in the market.

Based on our observations, not all players struggle enough to compete as they should be able to provide sufficient instrument such as promotional material, extension to field workers, partnership with distributors, manufacture scheduling and so on. In fact, only those who are capable to support all those things may stay steadily in the competition.

ITEMS OF PERMISSION ISSUED

Anytime permission is issued, Ministry of Agriculture releases one package of decrees consisting of:

  1. Permanent permission on new product, include those on renewal

  2. Label extension

  3. Permission on export product, include those on renewal

  4. Temporary permission, include those on renewal

  5. Permission on trial, include those on renewal

a. Permanent permission

Permanent permission will be granted as all technical and administrative requirements are completely fulfilled by the applicant. Validity data and any other technical information is the most important requirement for consideration. Complete but invalid data is subject to denial and permission would not be granted.

b. Label extension

Any additional target pest as well as commodity for label extension should comply with official procedure as it is supposed to be registered officially under the permission of Ministry of Agriculture. None of label extension is exempted from the obligation of registration.

c. Permission on export product

To any pesticide product intended for export is not required to follow the process of registration as it is for pesticides for use domestically. No trial report on toxicity and efficacy are required.

d. Temporary permission

If all data or information required may not be fulfilled as it is supposed to be, while basic information on efficacy and toxicity test are accomplished even some of them need to review further, temporary permission might be granted for one year period. Within the period, the applicant can submit additional data to upgrade the permission status.

e. Permission for trial

Pesticides for trial prior to be sold and used in the country or export must be registered and hold a permission from the Ministry of Agriculture. The permission is granted for 5 (five) years and can be prolonged for the same period.

REGISTERED CHEMICAL GROUP

The chemical group that has been registered in Indonesia comprise of:

1.

Phenoxy

16.

Quinthozine

31.

Amydine

2.

Organochlorine

17.

Triazole

32.

Avermectine

3.

Phridazinon

18.

Thiadiazine

33.

Dyphenil

4.

Pyrazol

19.

Benzimidazole

34.

Nerytoxin

5.

Tetrazine

20.

Acetamide

35.

Nitro Imidazoline

6.

Dithiocarbamate

21.

Benzoic Acid

36.

Neonicotinoid

7.

Phenol

22.

Bipiridylium

37.

Pyrol

8.

Benzymidazol

23.

Phenoxy

38.

Pyrethroid

9.

Dicarboximide

24.

Diphenyl Ether

39.

Cumarine

10.

Chloronitril

25.

Quinoxaline

40.

Indandione

11.

Imidazol

26.

Glycine

41.

Anylide

12.

Morpholine

27.

Oxadiazol

42.

Acetaldehyde

13.

Organophosphate

28.

Cyclohexane



14.

Oxazolidine

29.

Sulfonilurea



15.

Pyrimidine

30.

Thiocarbamate



DE-REGULATION ON PESTICIDE REGISTRATION

De-regulation on Pesticide Registration is reflected through the Ministry of Agriculture Decree No. 434.1 of 2001. It was officially implemented in September 2001. The following information is about the content of this regulation:

GENERAL DIRECTION

In the decree, the following description is given:

1.

Pesticides registration is a process to obtain a registration number as well as its permission.



2.

Pesticides are any chemical substances and other materials, microorganisms and virus which are intended to be used for the following:




a. To eradicate or prevent pests and diseases that devastate crops, part of crops and agricultural products;


b. To eradicate grasses;


c. To eradicate leaves and unexpected growth;


d. To regulate and stimulate plant growth and or its parts, except fertilizers;


e. To eradicate or prevent external pests on pets and animal husbandry;


f. To eradicate or prevent marine pests;


g. To eradicate or prevent any animal and microorganisms in the house, building construction, transportation means, and other;


h. To eradicate or prevent any animals causing diseases on either human being or animals by its use to plant, soil or water.



3.

General use pesticides are any pesticides for which no specific particular equipment and safety tools are required.



4.

Active ingredient is the chemical substance and or any other materials, as the major content of pesticide and it is generally a toxic substance.



5.

Analytical standard is a pure active substance, which is intended to be used to compare the test material when analyzing pesticides content.



6.

Technical material is a raw material to formulate pesticides resulting from the manufacturing process of the active ingredient and may contain impurities or certain additional substances



7.

Base technical material is a substance that resulted directly from the process of synthesis, extraction or other process to generate active ingredients.



8.

Processed technical materials is a substance that resulted from processing the base technical materials intended to gain safety, stability or other intention in the process of formulating, packaging, transporting and storing.



9.

Formulation is a mixture of active ingredients and other materials in a certain concentration and type of formulation having an action as pesticides.



10.

Any formulations with the same active are those pesticides formulations in which the entire active is technically equal.



11.

The national product of pesticide formulation are those being occupied by formulation's owners who are domiciled in the Republic of Indonesia



12.

Foreign product of pesticides formulation are those being occupied by formulation's owners who are not domiciled in the Republic of Indonesia



13.

Formulation owners are those either individual or legal entities who own the recipe of formulation



14.

Formulation recipe is information stating:




a. Items and amount of the active and other solvent in a certain formulation;


b. Methodology of formulating by the use of technical materials or active ingredients and other solvents.



15.

Applicants are anyone either as individual or legal entity who are submitting application for registration.



16.

Registration holders are those either individuals or legal entity who have held registration number and permission of pesticides as their responsibility.



17.

Distribution is a mechanism of import-export, buying-selling transaction in the country include its transportation.



18.

Storage is a state of being possessed pesticides as a stock keeper whether it is reserved at the yard, storeroom, traders or agriculture business.



19.

The use is the application of pesticides with or without associated tools as it is mentioned in point 2 above.



20.

Packaging is a physical material as a solid case, which is directly touch to pesticides.



21.

Label is written information which may be accompanied by pictures and/or symbol that provide information on such pesticides, and strongly stick to the container or packaging.



22.

Annihilation is proposed activity to demolish pesticides characteristic and its function.



23.

Restricted use pesticide is any pesticide as its use requires special requirement and equipment other than those are described in its label.



24.

The certificate of use is an official statement issued by the Chairman of the provincial/district/city pesticides inspection committee or the official concerned who declares that the certificate holder has been habituated to the procedure of use the RUP.



25.

The user are those individual or legal entity who deals with pesticides whether with or without equipment.



26.

Formulation name is a trade name of formulation that is proposed to registration.



27.

The name of technical grade is the trade name of technical grade that principally equal to the name of its active ingredient that is proposed to registration.



28.

Pesticides residue is the remaining substance of pesticide in certain amount includes the result of its changing in body tissue of human, animals, plant, water, air or soil.



29.

Acute toxicity is the adverse effect that immediately appears after exposure to a single dosage of chemical substance or other substances, or presenting double dosage in less than 24 hours period of time.



30.

Chronic toxicity is an adverse effect that appears due to the present of repetitive daily intake of chemical substances or other material, or the exposure to chemical substances last on the major part of the life cycle of organism for more than 50 percent, exposure period to the guinea pig within 2 years.



31.

Sub chronic toxicity is an adverse effect that appears due to repetitive daily intake of a chemical substance or other material, or the exposure to chemical substances, to the lesser parts of the life cycle of certain organism that used to be less than 10 percent, exposure period to the guinea pig within 3 months.



32.

Lethal dose 50 referred to as LD50 is a single dosage of chemical substances or other material which is drawn statistically that could be predicted to induce 50 percent death of organisms in a series of research.



33.

Lethal concentration 50 refer to LC50 is a concentration which is drawn statistically that could be predicted to induce death up to 50 percent of organisms in a series of experimental condition.



34.

Acceptable Daily Intake further refer as ADI is a particular number to predict the daily amount of chemicals in foodstuff enable to digest lifetime with no considerable risk.



35.

Maximum Residual Limit refer as MRL's is a predicted level of maximum pesticide's residue which is allowed to present on various agricultural product.



36.

Lethal Time 50 refer as LT50 is certain period of time which is daily basis required to kill 50 percent of guinea pig population in a certain condition.



37.

Decomposition Time refer as DT50 is a certain period of time required enable to decompose 50 percent of chemical substance.



38.

Director General is Director General of Agricultural Facility.



39.

Efficacy is the effectiveness of pesticides on target organisms for which to register based on the result of field trial or lab trial complies with the standard issued by Director General.



40.

Pest resurgence is an evidence of the increasing population of target pest as a result from pesticide application.



41.

Pest resistance is a phenomenon of population change that previously dominated by susceptible individual to be pest population dominated by resistance individual to certain pesticides. Such a change causes pesticides used to be effective turns less effective on certain pests.



42.

Irritation is a symptom of inflammation on skin or mucous membrane due to prolong or frequent application of chemical substances or other material.



43.

Carcinogenic is the property of certain material inducing cancer.



44.

Oncogenic is the property of certain chemical inducing tumor.



45.

Terratogenic is the property of chemical substance inducing abnormality on birth.



46.

Mutagenic is the property of chemical substance inducing genetic mutation.



47.

Weeds are those covers grasses as mentioned in the Government Act No. 7 of 1973.



48.

Prohibited pesticides are those officially forbidden to use for to all or certain uses to protect human health and sustainable environment and to comply with present regulation.



49.

Risk is the probability of harmful or adverse effect to human being or environment due to pesticides or chemical exposure.



50.

Risk evaluation covers qualitative and quantitative correlation between risk and benefit consists of complex process to determine the identified level of hazardous and risk identification to certain organisms or human related to or influenced by certain pesticides.



(1)

This decree is proposed to be a basic regulation in order to carry out pesticide registration, include trial and its permission.



(2)

The goal of this decree is as follows:




a. Protect the community and environment from adverse effects due to pesticide application;




b. Promote the efficiency and effectiveness of pesticides use;




c. Promote the IPM concept.

The scope of work of this decree covers classification, registration, including permission, container/packaging and pesticide label and administrative sanction.

Field of pesticides use is among:

  1. Crop cultivation
  2. Livestock and veterinary;
  3. Fisheries;
  4. Storage of agriculture products;
  5. Preservation of forests product;
  6. Controlling of human disease vector;
  7. Termite control;
  8. Household pesticides;
  9. Fumigation;
  10. Other industrial pesticides such as those impregnated in paint, anti pollution; and
  11. Other field.

CLASSIFICATION

(1)

Based on physical-chemical properties and its toxicity, pesticides can be classified into:




a. Pesticides which is eligible to be registered;


b. Prohibited pesticides.



(2)

Pesticides which is eligible to be registered as mentioned in point (1) a covers any pesticides not include those are in prohibited category as it is mentioned in point (3);



(3)

Prohibited pesticides as mentioned in point (1) b, are those holding criteria as follow:




a. Pesticides formulation is in the class Ia which is extremely danger and class Ib which is very danger due to WHO classification;




b. Having LC50 inhalation of formulation less than 0.05 mg/l for 4 hours exposure period;




c. Indicates carcinogenicity, terratogenicity, mutagenicity and oncogenicity evidence.



(4)

Based on its application method, pesticides can be classified into:




a. General use pesticides;




b. Restricted use pesticides.



(5)

Pesticides based on its method of application is classified as restricted use pesticides are those holding the following criteria:




a. Pesticide formulations corrosive to eyes (causing irreversible defect on ocular tissue) or may causes squeezing of cornea or irritation up to 7 (seven) days or more;




b. Pesticide formulations corrosive to skin (causes defect of inner dermis tissue and or left wounded) or causing severe irritation up to 72 hours or more;




c. When it is applied as described in the label, or due to regular practices such pesticides may still causes obvious sub chronic poisoning evidence, chronic or delayed to human as resulted from single or multiple exposure of pesticides or its residue.



(6)

Pesticides which are not included in such above criteria point (3) and point (4) are general use pesticides.



(7)

Minister of Agriculture have full rights to change the classification of restricted use pesticides to general use pesticides or prohibited pesticides based on recommendation given by Pesticides Committee.

Pesticides contents prohibited active ingredients are as follows:

1.

2, 3, 5-T

2.

2, 4, 5-Trichlorophenol

3.

2, 4, 6-Trichlorophenol

4.

Sodium 4-Brom-2, 5-Dichlorophenol

5.

Aldicarb

6.

Aldrin

7.

Arsonate (MSMA)

8.

Cyhexatin

9.

Dichloro Diphenyl Trichloroethane (DDT)

10.

Di Bromo Chloroprophane (DBCP)

11.

Dieldrin

12.

Dichlorophenol

13.

Dinozeb

14.

EPN

15.

Endrin

16.

Etylene Dibromidal (EDB)

17.

Red Phosfor

18.

Halogen phenol

19.

HCH and its isomers

20.

Haptachlor

21.

Captafol

22.

Chlordane

23.

Chlordimefon

24.

Leptophos

25.

Lindane

26.

Metoxychlor

27.

Mevinphos

28.

Monosodium metham

29.

Sodium chlorate

30.

Sodium tribromophenol

31.

Parathion methyl

32.

PCP and its salts

33.

Arsenic compound

34.

Mercury compound

35.

Strichnine

36.

Telodrine

37.

Toxaphene

(1) The application of Restricted Use Pesticides should comply to the following requirement:

  1. Anyone intents to use restricted use pesticides should hold certificate;

  2. Certificate could be provided to those who passed from training program on the use of restricted use pesticides organized by Pesticides Control Committee of provincial or county's level or any other officials concerned;

  3. Certificate is issued by Pesticides Control Committee of provincial or county's level or officials concerned valid throughout the country for 5 year and can be extended;

  4. Certification and training program on the use of restricted use pesticides is carried out as guided by technical guideline issued by Director General;

  5. Legal entity is permitted to use restricted use pesticides when trained employee applies it.

(2) Pesticides that are decided to be restricted use pesticides as shown and listed in annex 1.

TYPE OF PERMISSION

The type of pesticides permission consists of:

a. Trial permission;
b. Provisional permission;
c. Full registration (permanent permission).

Trial permission

(1) Trial permission is specified by Director General on the recommendation of Pesticides Committee for 1 (one) year period and can be extended up to 2 (two) times of one year period respectively.

(2) Trial permission is given as the applicant is supposed to proof their claim related to quality, efficacy and its safety.

(3) Trial permission holders are prohibited to use or distribute such pesticides commercially.

Provisional permission

(1) Provisional permission is granted by the Minister on the suggestion and recommendation given by Pesticide Committee to those pesticides fulfilled technical and administrative requirements for 1 (one) year period and can be prolonged 3 (three) times of one year period respectively.

(2) Provisional permission is granted as the applicant is supposed to complete the lack of technical and administrative data and information as required. The application will be denied when that technical and administrative requirement is unable to be completed.

(3) For those pesticides holding provisional permission can be manufactured or distributed in limited amount set officially by the Ministerial Decree due to the number of commodity, dosage or concentration and its application.

(4) When the use of pesticides as affirmed in point (4) has proven to impose negative impact to human health and or sustainable environment, such permission might be reviewed.

Full registration

(1) Full registration or permanent permission is granted by the Minister on the suggestion and recommendation given by Pesticides Committee as all technical and administrative requirement are fulfilled by the applicant. Valid for 5 (five) year period.

(2) Pesticides holding full registration can be used and distributed on commercial basis.

(3) When the use of pesticides as affirmed in point (1) has proven to impose negative impact to human health and or sustainable environment, such permission might be reviewed.

REQUIREMENT OF REGISTRATION

The application of pesticides registration can be done by Indonesian citizen as individual or legal entity that meets the following requirements:

a. Official legal entity

b. Trade Permission issued by the Minister of Trade and Industry

c. Tax Number

d. Identity Card

e. Formulation's owner or their authorized

f. The representative office as the Indonesian legal entity who are appointed by the formulation owner

(1) Those are eligible to be registered in Indonesia are those not included prohibited pesticides

(2) Pesticides formulation consists of:

a. National product
b. Foreign product

(3) The national products have to comply with the following requirements:

  1. Any product belonging to either an individual or firm with the Indonesian legal entity whose eligible;

  2. Being formulated in the country or abroad by the use of technical which is produced either in the country or imported;

  3. The purities of technical complies to FAO standard or recognized national standard.

(4) Foreign products have to comply with the following requirements:

  1. Being formulated abroad while the technical is produced by formulation owner themselves or it is produced by any other parties who are in agreement with the formulation owner in producing technical;

  2. Being formulated in the country while the technical is produced by the formulation owner themselves or it is produced by any other parties who are in agreement with the formulation owner in producing technical, or other parties whose produce such technical in the country;

  3. The purities of technical comply to FAO standard or recognized national standard.

Submission of registration not only has to comply to the requirement as mentioned above but also has to fulfill the following requirement:

  1. Any formulation produced by the formulation owner, which is intended for all field of usage, have to be registered on behalf of one single applicant;

  2. Formulations with identical active ingredient whether single or multiple which is produced by one formulation owner and is intended to use to one specific field of usage is only can be registered on behalf of one applicant;

  3. Formulations in identical type as well as its active ingredients whether single or multiple whish is produced by one owner, and is intended to use to one specific field of usage and by the use of similar equipment, there is only one formulation can be registered by one applicant.

Pesticides formulation with multiple active ingredients for all use must not generate antagonism effect and may help reduced negative impact to the natural enemies and environment.

(1) All pesticides for registration must be specified through its own name as it identifies each formulation that will be distributed;

(2) The trade name as mentioned in point (1) may not be the same or similar to any registered formulation;

(3) The trade name as mentioned in point (1) has to comply the following requirement:

  1. Each formulation is only been given one trade name consists of 3 (three) elements i.e. the name not related to common name and or the name of active ingredient, number that shows the concentration of the active ingredient and code that shows the formulation type;

  2. Each formulation name for registration must be accompanied by the verified document of registration of the intellectual proprietary rights (IPR);

  3. Any formulation with equal active ingredient can only be registered on one trade name for one single field of usage;

  4. Any formulation with different active ingredient of one formulation's owner can only be registered in different trade name for any field of usage;

  5. Any formulation with multiple active ingredients in which one of them is equal to the active ingredient of other formulation for any field of usage of the same formulation's owner can be registered in the same trade name;

  6. The name of formulation as described in the letter a through e are not supposed to be provocative such as super, bombastic, strong and so on.

(4) The trade name of technical have to comply to the requirement as described in point (3) and have to be pursued by number and code that shows concentration of its active and type of technical respectively.

PROCEDURE OF REGISTRATION

(1) The application for registration is submitted officially to Director General of Agriculture Facility with sufficient legal stamp based on the existing regulation by the use of the application form as shown in annex II of this decree.

(2) The application as described in point (1) is accompanied by complete set of requirement as the directive that is mentioned above.

(3) The application can be accepted when all requirements as mentioned above by completing all necessary information required in the application form.

(4) Once the application of registration is accepted as mentioned in point (1) in a complete set and properly, Director General within 30 (thirty) days at the latest has done in checking and evaluating all document collaborating with Pesticides Committee.

(5) After being evaluated as mentioned in point (4) based on suggestion and recommendation of Pesticides Committee, Director General within 14 (fourteen) days at the latest granting Trial permission, suspending or denying.

(6) In case of suspension or detention of application as mentioned in point (5) Director General shall inform the applicant with sufficient reasons on written notice.

(5) The applicant will be granted prolonged opportunity to complete or renew all related documents once Director General issuing the notice as mentioned above.

(6) After obtaining Trial Permission, the applicant submit pesticides sample immediately to Director General to process quality assurance test at the accredited laboratory. In case of lack of accredited laboratory, such a test may be done by recognized laboratory.

(7) The result of quality assurance test as mentioned in point (6) must be submitted to Director General and the Director General within 7 (seven) working days has evaluated by applying standard methodology set up by Director General on the suggestion of Pesticides Committee. When such sample fulfills the requirement, it will be sealed.

(3) In case of the result of quality assurance test of the sample as mentioned in point

(7) do not meet the requirement, Director General will inform the applicant to redo such a test.

(8) Once the applicant obtained tested sample as mentioned in point (7) immediately submit the sample sealed by Director General to accredited research institute or other research institutions appointed by Director General to execute efficacy and toxicity test.

(9) The efficacy test as well as toxicity test that will be done by such institution as mentioned in point (8) should comply to the standard methodology set up by Director General base on the recommendation of Pesticides Committee.

(10) When all test are done, the research institute should provide test report to the applicant as one copy is also being addressed to Director General.

(11) The test result as mentioned in point (10) is submitted to Director General officially by the applicant for further evaluation comply to the procedure of evaluation technical data.

(12) Based on evaluation as mentioned in point (11) the application for registration may be accepted or refused.

(13) Director General on the suggestion of Pesticides Committee within 90 (ninety) days at the latest has submitted the draft of minister decree.

(14) The Minister of Agriculture Decree with regards to the number of registration and temporally permission is set up when:

a. Further tests on its safety to the environment and human health are needed;

b. The present of efficacy data was done by other than the institution as mentioned in point (9).

(15) The procedure of registration as mentioned above through are also applicable to the registration of technical and pesticides for export but the following tests i.e. efficacy, environment toxicity, resistant, resurgence and residual.

(16) The application form for technical registration is provided.

(17) The registration number that has been granted whether in the temporally permission of full registration could be transferred or be moved due to:

a. The formulation owner appointed other party as the registration holder;

b. The formulation owner transferred its ownership to other party;

c. Other party has been appointed as the registration holder due to the company's merger;

d. The change name of formulation owner or the registration holder.

(18) The party who are assigned as the new registration holder as mentioned in point (17) are required to elucidate any problems due to such change between the previous and the present holder and then report it to the Director general as the Director General will proceed such change to be set up.

(19) The alteration on the registration consists of the change of:

a. The name of formulation or technical;
b. Wrap and packaging;
c. Source of technical.

(20) Any changing as mentioned in point (19) must be reported by the registration holder to Director General for further process.

(21) Pesticides hold full registration that has expired might be reregistered by following the procedure as described in this decree.

(22) To reregister such permission as mentioned in point (21) has to be done 2 (two) months before expiration date. When it is not being done the registration number and its permission is terminated due to the law.

(23) In the process of re registration as mentioned in point (222), new test might be required as the indication of negative impact is in evidence.

(24) The kind of test to obtain new data as mentioned in point (3) are set up by Director General based on the recommendation of Pesticides Committee.

(25) The decision of Director General to execute the test as mentioned in point (24) is informed to registration holder within 2 (two) years before expiration date at the latest.

PACKAGING AND LABELING

Labeling

(1) Any pesticides holding Temporally permission as well as full registration must be placed in particular container.

(2) The container must not so delicate or tore or being protected by another container as it will not easy to shred, does not react to pesticides or corrosive as it brings no harm to human being and environment.

(3) Each container must be properly closed or folded or such fold can not be opened unless destroying it except without destroy it, the pesticides can release on the form of fog.

(4) The specification of container must be thoroughly described consists of volume, name of material, shape, size, thickness of material, color, coated of the inner side and material of cap.

Packaging

(1) Each container must be given label that is strongly stick as it does not easy to lose or direct printed on the container.

(2) The registration holder and as being requested for registration suggest Pesticides label

(3) All information describe on the label and its attachment are written in Indonesia whereas foreign language are acceptable only for translating the important information for which also being mentioned in Indonesia.

(4) Information and warning signs of hazards on the label must be clearly printed out, easy to be read or seen and resist to pesticides and un erasable.

(5) Complete information of label content, warning statement and safety guidelines, symptom of poisoning, first aid information, storage, direction of use, pictogram, label for restricted use pesticides and the organizing of label as mentioned in annex of this decree

RESPONSIBILITY OF OFFICER AND REGISTRATION HOLDER

(1) Officer or researchers of research institutions, laboratory and service officers have to keep the truth and stay classified all data and information as due to its characteristic need to be kept confidential.

(2) Directorate General have to organize a book of registration number and record anything regarding transformation of whether subject or object of registration.

(1) Registration holder has to declare the number of registration on the container/packaging and or label.

(2) Registration holder has to pay registration fee as the government revenue of non taxes and must be executed to the government's treasure as its amount is set up by law.

(3) Registration holder will bear all experiment expenses as for such amount and procedures will be set up by the institution concerned.

(1) Registration holder has to submit 2 (two) grams of analytical standard accompanied by its certificate of analysis once in two years to Director General to be kept at the laboratory

(2) Registration holder has to submit annual report on production and distribution as well as its technical consists of import export and domestic transaction, and 6 (six) monthly report on production and distribution of restricted use pesticides to Director General by the use of reporting form as annex VIII.

(3) Registration holder of the restricted use pesticides has to provide product stewardship and taking any action on adverse affect due to misuse pesticides.

ADMINISTRATIVE SANCTION

To the institution and or experimental laboratory who are proven unable to secure the secret and the truth of test result that was done, will be given written correction by Director General and will be reported to the authorized concerned for further sanction based on law.

Service officer in registration who are proven unable to secure the secret of data will be laid a discipline sanction for government official due to government law.

(1) To the registration holders who are proven not to declare number of registration on label and or unable to assure the quality or neglect to report the evidence of the change of registration holders will be laid a sanction which is withdrawn such number of registration, its permission and distribution.

(2) Registration holders who have never been producing and or importing or never been reporting for 2 (two) consecutive year will be laid sanction which is withdrawn the number of registration and the product.

TRANSITION RULE

(1) Any pesticides when this decree is enacted has been registered and holding full registration or temporally permission is being granted up to the expiration date.

(2) Any pesticides when this decree is enacted have been on going process of trial intended for registration, will be proceeding comply with the old regulation.

(3) Any pesticides when this decree is enacted have been applied for registration whereas none of trial is being done, the applicant should comply with this regulation.

(4) Any registered pesticides with the trade name set up prior to this decree, should be reregistered with the trade name complies to this decree.

QUESTIONNAIRE SUMMARY

Indonesia

Selected Country Statistics:

Agricultural Population

93.0 million

Agricultural Land

33.7 million ha

GDP $208 311 million

Agric. GDP: 17.5%

GNI per capita: $810

Hunger: 6%

FAOSTAT Pesticide Data

Export $48.7 million

Import: $50.3 million

Use: ton

GDP = Gross Domestic Product; GNI = Gross National Income; Hunger = Population below minimum energy requirement; FAOSTAT = latest data entry between 1998 and 2002

Institutional Profile

Ministry

Legislation

Registration

Licensing

Enforcement

Testing

Training

Monitoring

Environm.

Health

Agriculture









Environment









Health









Other




Police





Industry Assoäations: Non-Governmental Assoäations:

A. Pest and Pesticide Management

IPM policy declared?

Yes

IPM mentioned in...



Crop Protection Policy?

Yes

Agric. Sector Policy?

Yes

Other laws/documents?

Yes

National IPM Program?

Yes



Dept:


IPM extension projects?

?

IPM research projects?

?

Pest resistance problems?

Yes


B. Testing, Quality Control and Effects

Laws for pesticide specifications?

Yes

Low quality products in market?

Yes

Quality control laboratory?

Yes


Own analyses in 2004:


Outside analyses in 2004:



C. Health and Environmental Information

Data on pesticide poisoning cases?

-


occupational exposure cases:


accidental exposure cases:


intentional/suicide cases:


Pesticide poison facilities?

-


Number of facilities:


Poison Information and Control Centers?

-


Number of centers:


Significant environmental contamination?

Yes

Data on effects on wildlife & ecosystems?

-

Pesticide residue monitoring system?

-


Number of analyses 2004:



D. Pesticide Manufacture, Use and Trade

Pesticide Volume

Tons

$'000 Value

Imports



Manufacture



Exports



Sales






Pesticide Use Profile

Tons

$'000 Value




Agriculture (total)




Insecticides



Fungicides



Herbicides



Other



Veterinary



Public Health



Household



Other



TOTAL




E. Selected Standards of Code of Conduct

Illegal trade estimates?

-


Estimated amount 2004


Collection of old containers and pesticides?

Yes

Inventory of outdated/obsolete products?

Yes

Operational pesticide registration system?

Yes


Violations in 2004


Existing facility licensing system?

Yes


Inspections in 2004


Highly toxic products restricted?

Yes

Questionnaire responses: Yes = Yes; - = No;? = don't know; (blank) = no answer


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