Pesticide Regulation in Thailand - 亚太cacasiasummit.com/Uploads/Download/1-pesticide regulation_Mr Saran.pdf · Saran Watanatada Department of Agriculture Regulations 1. The government

Pesticide Regulation in Thailand

Saran Watanatada Department of Agriculture

Regulations

1. The government of Thailand enacted the Poisonous Article Act B.E. 2510 in 1967 for control of pesticide.

2. Replaced by the Hazardous Substance Act B.E. 2535 (1992), effective since April 7, 1992.

3. Currently - the Hazardous Substance Act (No. 3) B.E. 2551 (2008), effective since 26 February, 2008.

1967 Poisonous Article Act B.E. 2510 replace by

1992 Hazardous Substance Act B.E. 2535 2001 Hazardous Substance Act (No.2) B.E. 2544 2008 Hazardous Substance Act (No.3) B.E. 2551

REGULATION SYSTEM

All hazardous substances in agriculture,

industry, public health and others, are

regulated under the Hazardous

Substance Act.

The Hazardous Substance Committee is the

main committee to set up policies and

collaborate implementation of the Hazardous

Substance Act

Among responsible agencies (Agriculture,

Industry, Public Health, etc.).

The Department of Agriculture (DOA) is the responsible

agency to regulate hazardous substances used in crop

production.

1. Insecticide

2. Fungicide

3. Herbicide

4. Rodenticide

5. Acaricide

6. Molluscicide

7. Nematicide

8. Plant growth regulator

Pesticide registration is approved by Sub-committee for consideration of pesticide registration, chaired by Director-General, Department of Agriculture.

The hazardous substances are classified into 4 types according to the needs for control.

Type 1 the production, import, export or possession must be complied with the specified criteria and procedures; no need to apply for a registration or license

Type 2 production, import, export or possession must be notified to authorities; production and import must be registered; no need to apply for license

Type 3

production, import, export or possession must be applied for license; production and import must be registered

Type 4 production, import, export or having in possession are prohibited (banned pesticides)

- At present, no hazardous substances used in agriculture are classified as type I - Most of them are classified as type III - Only some low toxic pesticides as well as some

bio-pesticides e.g.

: neem extract : Bacillus thuringiensis : Nuclear Polyhedrosis Virus (NPV) : nematodes

: white oil are classified as Type II

Control measures for Pesticide

1.Registration

2.Licensing

3.Monitoring

1. Registration 1. Risk/Benefit Assessment process to

select pesticide for use

2. There are two types of registration.

- import registration

- production registration

There are 3 phases of registration:

1. Trials clearance

2. Provisional or Demonstration clearance

3. Full Registration

Registration Steps Trials Clearance

(Approval 3-6 months)

Provisional Clearance (Approval 1 years)

Full Registration (Approval 1 years)

Duration of Registration Certificate 6 Years

Trials clearance

• efficacy test (2 seasons or 2 locations)

• acute toxicity

• sample is allowed to be imported for – efficacy test

– quality analysis.

Provisional or Demonstration clearance

• demonstrate efficacy test in farmers’ field

• sub-chronic toxicity and effects to the ecosystem.

Full Registration

• to make decision whether the pesticide is accepted for use or not

• this step requires result of assessment of chronic toxicity including data from 2-year feeding study in test animal

• efficacy test result and quality analysis result.

Data requirements for pesticide registration

• Adopted from FAO Guidelines for Pesticide Registration.

• Information relating to toxicity of technical grade material and finished product

• Must be generated by the GLP Certified Laboratory according to OECD standard

Toxicological data on the technical grade material

1. Acute oral toxicity 2. Acute dermal toxicity 3. Inhalation toxicity 4. Skin irritation 5. Eye irritation 6. Skin or dermal sensitization 7. Sub-acute studies 8. Teratology / reproductive studies 9. Mutagenicity studies 10. Chronic studies (2 years) 11. Residue data 12. Effects on the environment and wildlife

Toxicological data on the finished product

1. Acute oral toxicity

2. Acute dermal toxicity

3. Inhalation toxicity

4. Skin irritation

5. Eye irritation

6. Skin or dermal sensitization

7. Precaution for usage and storage

8. Diagnosis of poisoning, specific signs of poisoning, clinical tests

9. First aid measure

10. Medical treatment

Special requirements under new regulations

• Letter of authorization from manufacturer/sponsor giving permission to the registrant to use data for registration.

• Registration and/or license certificate in manufacturing country.

If 4 components have been accepted by concerned agencies:

1. Efficacy test result

2. Toxicological data assessment result

3. Quality analysis result

4. Residue data assessment result

The Registration Sub-Committee shall approve and certificate for registration shall be issued.

Efficacy report

Residue report

Tox approval

Sample analysis result

Registration committee

(Approve registration & draft label)

Issuing Registration Certificate

Validity of Registration

- Before Hazardous Substance Act No. 3 2551 (2008), registration has no expiry date.

- Nowadays, registration certificate valid for 6 years and can be extended.

2. Licensing – the control measure after registration.

- import

- production

- export

- having in possession

IMPORT LICENSE

Before issuing import license, it is needed to check accordingly:

• - Storage site - Registration Certificate (Import) - Proforma Invoice - Certificate of Analysis

Before issuing production license, it is needed to check accordingly:

- Production/ Storage site - Machines & instruments - Safety measure/accident prevention - Waste management/Pollution control - Registration Certificate (Production) - Label/Container

PRODUCTION LICENSE

Before issuing export license, it is needed to check accordingly:

- Registration Certificate (Import or production)

- Registration Certificate in the country

of destination

- Certificate of Analysis

EXPORT LICENSE

Before issuing possession license, it is needed to check accordingly:

- location - Shelving - Transportation - Safety measure/accident

prevention - Certificate on training for sale

supervisor arranged by DOA - Provide sale supervisor who has attended

the training programs on hazardous substance trained by the Department of Agriculture

POSSESSION LICENSE

3. Monitoring

– the control measure for ensuring quality of pesticide to comply with registration

- standard by taking sample for analysis at

- port of entry

- production factory

- market

Monitoring

1. Import - Taking sample for analysis, result

must comply with registration standard before clearance

- Check packaging - Check label

2.Production

- Taking sample for analysis

- check packaging

- check label

- inspect storage condition

Monitoring

3. Marketing

- Check registration number on label

- Taking sample for analysis

- Check packaging size to comply with registration certificate

- Check container condition (leakage/distorted/deformed)

- label (Thai language only)

Monitoring

year ton Million US (1 U$$ = 35 baht)

2010 117,776 560

2011 164,538 689

2012 134,480 605

2013 172,673 761

2014 147,269 633

2015 149,458 551

Import statistic (ton)

0

20000

40000

60000

80000

100000

120000

140000

160000

2010 2011 2012 2013 2014 2015

herbicide

insecticide

fungicide

year ton Million US (1 U$$ = 35 baht)

glyphosate-isopropylammonium 58,078 88

paraquat dichloride 30,440 76

2,4-D dimethyl ammonium 5,929 10

Ametryn 3,990 16

atrazine 3,983 14

country ton Million US (1 U$$ = 35 baht)

China 110,650 275

India 8,471 51

Malaysia 7,682 17

Taiwan 5,380 14

Israel 4,341 24

Indonesia 2,614 17

Thank you

for

your attention