A Review Of Public Health Pesticides Registration System In Selected SEA Countries

A Review Of Public Health Pesticides Registration System In Selected SEA Countries By Halimi Mahmud Pesticides Board, Malaysia International Public Health Pesticides Workshop 29 September - 1 October 2009, Geneva, Switzerland

Topics 1. SEA legislative framework 2. Type of market authorization 3. Registration authority 4. Type of registration clearance 5. Data requirements for registration 6. Local data and acceptability 7. Approval process 8. Registration timeframe and validity of registration 9. Issues and challenges 10. Proposals and recommendations 11. ASEAN harmonization efforts

SEA legislative framework Wide difference in level of management and control among countries. Legislations are already in place to regulate pesticides but some are facing problems in their implementation due to lack of expertise.

Type of market authorization Mandatory registration in-country before marketing Indonesia Malaysia Philippines Singapore Thailand Vietnam Proof of registration in other country as a condition before marketing Cambodia Lao No registration required Brunei Darussalam

Registration Authority Together With Agricultural Pesticides Indonesia Pesticides Board, MOA Malaysia Pesticides Board, MOA Separated from Agricultural Pesticides Singapore National Environmental Agency, MOE Thailand Food & Drug Administration, MOH Philippines Food & Drug Administration, MOH

Type of registration clearance Phase registration Provisional clearance (Generation of data) Temporary clearance (Limited business activity) Permanent clearance (Full business activity) e.g. Indonesia, Thailand and Myanmar Full registration Only full registration system is implemented. Importation of limited amount of unregistered pesticides is through Import Permit e.g. Malaysia and Singapore

PHPs that may be registered Indonesia All pesticides may be registered except o Class Ia & Ib pesticides of WHO Hazard classification o Pesticides with LC50 inhalation < 0.05 mg/l o CMR pesticides Malaysia Commodity Pesticides Active ingredients which have been sold in the world market for not less than 15 years and which have been registered in Malaysia not less than 6 years Proprietary Pesticides All pesticides other than the above

PHPs that may be registered Singapore Publishes a list of A.I. that can be registered o o General use Restricted use (applied by PCO) Thailand Toxic substance categories: o o o o Type 1 (Generally no registration required) Type 2 (Most PHPs fall here) Type 3 (Most PHPs fall here) Type 4 (Prohibited chemicals)

Data Requirements for Registration 1. Impacts on human and animal (A.I.) 2. Impacts on the environment (A.I.) 3. Effects on non-target organisms (A.I) 4. Bio-efficacy data (Formulation) 5. Physical and chemical properties (A.I. and formulation) 6. Product specifications (A.I. and formulation)

Data Requirements for Registration (Cont ) 7. MSDS 8. Manufacturing process 9. Stability test 10. Method Of Analysis 11. Sample of the product 12. Classification and labeling 13. Registration status in other countries 14. Free sale certificate from other countries (some countries require certification by the Embassy)

Local Data Requirements Bio-efficacy data Exposure study to enable risk assessment to be carried out under local conditions

Acceptability of bio-efficacy data Local data o Generated by government institutions (Indonesia) o Generated by applicant or institutions (Malaysia and Thailand) Data generated in other countries of similar climatic conditions may be accepted (Malaysia)

Acceptability of bio-efficacy data Recommendations of International Organisations (e.g. WHOPES and others) Generation of data must be done according to acceptable protocols (Some countries insist to follow national protocols if available otherwise international protocols may be used)

Approval process Decisions are often made by a Committee (e.g. Board, Pesticide Technical/Advisory Committee), which may be responsible for the final decision or for making a recommendation to the appropriate government officials. Committee is essentially comprises of personnel from key government agencies such as Agriculture, Health, Environment, Research Institutes, Consumers, Trade and Industry etc.

Registration timeframe Ranging from 3 12 months to register a product 12 10 8 6 4 2 0 12 12 9 3 3 Indonesia Malaysia Philippines Thailand Singapore Months

Validity of registration Ranging from 3 years to 5 years and re-registration before expiry dates Perpetual registration (Singapore and Thailand) 5 4.5 4 3.5 3 2.5 2 1.5 1 5 5 5 3 Philippines Vietnam Indonesia Malaysia Years

Issues and Challenges Non-existence of pesticides regulatory harmonization system in terms of: Harmonized registration systems and procedures Harmonized data requirements Harmonized evaluation procedure Harmonized classification system Harmonized labeling requirements Non-existence of mechanism for work sharing among countries: Joint registration review Data generation Bio-efficacy and risk assessment Transportability of data No mutual recognition of registration system and institutions generating the data

Issues and Challenges Minor uses Most minor uses are evaluated following major uses procedures Without the supporting data, no authorization is granted Quality control facilities An important requirement in a good registration scheme Many developing countries do not have quality control facilities

Issues and Challenges Unauthorized uses and violation of label recommendations Major contribution to ineffective use, wastage, adverse effects and possibly resistant development Lack of awareness among users on effective and safe use education and training Substandard products Lack of enforcement Lack of post registration monitoring of the products in the market Lack of expertise in data evaluation Under resources Need for capacity building

Proposals & Recommendations Harmonization of registration system and evaluation/assessment procedures More guidance from International bodies e.g. WHOPES, FAO, JMPS, JMPM, OECD and regional bodies Guidelines on generic assessment procedures FAO/WHO specifications Expedited registration process for certain pesticides e.g. minimum risk pesticides, IGR and bio-pesticides Need guidance

Proposals & Recommendations Creating pool of experts at international level to assist developing countries in registration matters Incentives to producer - data protection and exclusivity Effective enforcement of distribution and use of illegal pesticides Capacity building

ASEAN Initiative Towards Pesticide Regulatory Harmonization Currently in the process of requesting for financial assistance from FAO (FAO Technical Cooperation Program) - Assisting ASEAN Countries Towards Achieving Pesticide Regulatory Harmonization Project Components 1. Harmonization of registration requirements; 2. Harmonization of bio-pesticide registration requirements; 3. Harmonization of pesticide labeling; 4. Training in risk assessment; 5. Training in pesticide formulation analysis; 6. Training in pesticide residue analysis; 7. Bio-efficacy test protocols; 8. Information exchange

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