FPA GreenBook PDF

TABLE OF CONTENTS
MESSAGE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x
FOREWORD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xi
PREFACE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xiii
Chapter 1 MANDATE AND STRUCTURE OF THE FERTILIZER AND 1

PESTICIDE AUTHORITY PERTAINING TO PESTICIDE
REGULATION
1.1 MANDATE AND FUNCTIONS OF THE FERTILIZER AND

PESTICIDE AUTHORITY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
1.2 ORGANIZATIONAL STRUCTURE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Chapter 2 REGISTRATION OF CHEMICAL PESTICIDES 5
2.1 GENERAL INFORMATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

2.1.1 Legal Basis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
2.1.2 Pesticide Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
2.1.3 Purpose of Registration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
2.1.4 Classification of Pesticides for Registration Purposes . . . . . . . . . . . . 7
2.1.5 Types of Products to be Registered . . . . . . . . . . . . . . . . . . . . . . . . . . 8
2.1.6 Types of Registration Granted . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
2.1.7 Miscellaneous Regulations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
2.2 APPLICATION FOR REGISTRATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

2.2.1 Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
2.2.2 Steps In Processing An Application . . . . . . . . . . . . . . . . . . . . . . . . . . 14
2.2.3 Estimated Timetable for Review Process . . . . . . . . . . . . . . . . . . . . . . 14
2.2.4 Period of Validity and Renewal of Registration . . . . . . . . . . . . . . . . . . 17
2.2.5 Re-Registration and Renewal Requirements . . . . . . . . . . . . . . . . . . . 17
2.2.6 Fees . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
2.2.7 Maintenance of Official FPA Lists of Registered Products
and Uses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
2.3 DATA REQUIREMENTS FOR REGISTRATION AND

EXPERIMENTAL USE PERMIT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
2.3.1 General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
2.3.2 Chemical Pesticides . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
2.4 EXPERIMENTAL USE PERMITS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

2.4.2 Types of Experimental Use Permits (EUP) . . . . . . . . . . . . . . . . . . . . . 24
2.4.3 Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
2.4.4 Data Requirement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
2.4.5 Validity and Extension . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
i
2.5 EXPLANATORY NOTES ON TYPES AND USE OF REQUIRED
DATA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
2.5.1 Test Substance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
2.5.2 Identification of Registrant, Product, Manufacturing Process . . . . . . . 25
2.5.3 Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
2.5.4 Bioefficacy Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
2.5.5 Toxicology Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
2.5.6 Human Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
2.5.7 Environmental Effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
2.5.8 Environmental Fate and Transport . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
2.5.9 Residues in Food . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
2.6 GROUNDS FOR DENIAL OF REGISTRATION . . . . . . . . . . . . . . . . . . . . . . . 32
2.7 OBLIGATIONS OF REGISTRANTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
2.8 LABELLING REQUIREMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

2.8.2 Purpose of the Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
2.8.3 General Considerations on Labelling . . . . . . . . . . . . . . . . . . . . . . . . . 35
2.8.4 Specific Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
2.8.5 Classification on the Basis of Toxicity and Hazard . . . . . . . . . . . . . . . 40
2.8.6 Criteria for Classification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
2.9 SAMPLE STATEMENTS: WARNING AND PRECAUTIONS,

SYMPTOMS, FIRST AID AND TREATMENT, AND INFORMATION
FOR PHYSICIANS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
2.9.1 Warning Statements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
2.9.2 Precautionary Statements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
2.9.3 Mandatory Statements based upon Secondary Hazard . . . . . . . . . . . 44
2.9.4 Signs, Symptoms and Treatment of Poisoning . . . . . . . . . . . . . . . . . . 44
2.9.5 First Aid Statements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
2.9.6 Special Note on Emulsifiable Concentrates and Other
Formulations with Hydrocarbon Solvents . . . . . . . . . . . . . . . . . . . . . . 46
2.9.7 Information for Physicians . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
2.9.8 Position of Information on the Label . . . . . . . . . . . . . . . . . . . . . . . . . . 49
2.9.9 Sample Pesticide Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
2.10 REFERENCES TO ACCEPTABLE PROTOCOL . . . . . . . . . . . . . . . . . . . . . . 49
Chapter 3 POLICY GUIDELINES ON BIORATIONAL PESTICIDES 64
3.1 DEFINITION AND SCOPE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65

3.1.1 Definition of Biorational Pesticides . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
3.1.2 Biochemical Pest Control Agents . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
3.1.3 Microbial Pest Control Agents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
3.1.4 Pest Control Organisms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
ii
3.2 REGULATION OF BIORATIONAL PESTICIDES . . . . . . . . . . . . . . . . . . . . . . 67
3.2.1 Policy Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
3.2.2 Approach to Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
3.3 PRODUCT SPECIFICATION DATA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69

3.3.1 Scope of Product Analysis Requirements . . . . . . . . . . . . . . . . . . . . . . 69
3.3.2 Guidelines for Biochemical Pest Control Agents . . . . . . . . . . . . . . . . 69
3.3.3 Product Analysis Guidelines for Microbial Pest Control Agents . . . . . 72
3.4 TOXICOLOGY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
3.4.1 Major Concerns . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
3.4.2 Biochemical Agents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
3.4.3 Microbial Agents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
3.4.4 Toxicology Data Guidelines for Biochemical Agents . . . . . . . . . . . . . 76
3.4.5 Toxicology Data Guidelines for Microbial Agents . . . . . . . . . . . . . . . . 77
3.5 RESIDUE ANALYSIS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77

3.5.1 Biochemical Pest Control Agents . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
3.6 NON-TARGET ORGANISM HAZARD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80

3.6.1 Biochemical Agents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
3.7 ENVIRONMENTAL FATE AND EXPRESSION . . . . . . . . . . . . . . . . . . . . . . . 89

3.7.1 Biochemical Pest Control Agents: Environmental Fate
Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
3.7.2 Microbial Pest Control Agents: Environmental Expression
Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
3.8 PRODUCT PERFORMANCE DATA REQUIREMENTS . . . . . . . . . . . . . . . . 92

3.8.1 General Provisions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92
3.8.2 Specific Provisions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93
3.9 EXPERIMENTAL USE PERMIT GUIDELINES . . . . . . . . . . . . . . . . . . . . . . . 93

3.9.1 Scope and Intent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93
3.9.2 General and Specific Provisions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93
3.10 PROMOTING BIORATIONAL PESTICIDES . . . . . . . . . . . . . . . . . . . . . . . . . 96

3.10.1 Approach . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96
3.10.2 Product Label Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96
Chapter 4 LICENSING, CERTIFICATION AND ACCREDITATION OF 109

PESTICIDE HANDLERS
4.1 LEGAL BASIS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110
4.2 APPLICATION AND REQUIREMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110

4.2.1 Licensing of Pesticide Companies and Other Handlers . . . . . . . . . . . 110
4.2.2 Licensing of Dealers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111
iii
4.3 VALIDITY, RENEWAL AND FEE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112
4.4 “GOOD HOUSEKEEPING” REQUIREMENT FOR LICENSING OF

PESTICIDE DEALERS AND DISTRIBUTORS . . . . . . . . . . . . . . . . . . . . . . . . 112
4.5 CERTIFICATION AND ACCREDITATION . . . . . . . . . . . . . . . . . . . . . . . . . . . 113

4.5.1 Certified Pesticide Applicators (CPA) . . . . . . . . . . . . . . . . . . . . . . . . . 113
4.5.2 Accreditation of Professional Pesticide Adviser . . . . . . . . . . . . . . . . . 115
4.5.3 Accredited Responsible Care Officer (ARCO), Master
Instructor - Responsible Care Officer (MI-RCO) and
Responsible Care Officer (RCO) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117
4.5.4 Accredited Pesticide Dispenser (APD) . . . . . . . . . . . . . . . . . . . . . . . . 119
4.5.5 Accreditation of Researchers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119
4.5.6 Accreditation of Pesticide Formulation and Residue
Laboratory(s) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121
4.5.7 Procedure for Revocation of Accreditation,
Certification and Licenses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123
Chapter 5 PRODUCT STEWARDSHIP AND RESPONSIBLE CARE 126
5.1 GENERAL INFORMATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127

5.1.1 Policy Guidelines on Product Stewardship . . . . . . . . . . . . . . . . . . . . . 127
5.1.2 Performance Review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128
5.1.3 Penalty for Violations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128
5.2 RESTRICTIONS ON AVAILABILITY AND USE . . . . . . . . . . . . . . . . . . . . . . . 128

5.2.2 Basis for Restrictions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129
5.2.3 Restriction Categories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130
5.2.4 Pesticides For Institutional Use Only . . . . . . . . . . . . . . . . . . . . . . . . . 131
5.2.5 Use of Pilot Areas . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132
5.2.6 Pesticides for Certified Pesticide Applicator Use Only . . . . . . . . . . . . 133
5.2.7 List of Banned and Restricted Pesticides . . . . . . . . . . . . . . . . . . . . . 133
5.3 FORMULATION AND PACKING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133

5.3.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133
5.3.2 Safety, Health and Environmental Aspects . . . . . . . . . . . . . . . . . . . . . 135
5.4. PACKAGING MATERIALS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139

5.4.1 Packaging Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139
5.4.2 Regulatory Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141
5.5 TRANSPORT, STORAGE, AND DISPOSAL . . . . . . . . . . . . . . . . . . . . . . . . . 148

5.5.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148
5.5.2 Transport . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149
5.5.3 Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151
5.5.4 Leaks, Spills and Decontamination . . . . . . . . . . . . . . . . . . . . . . . . . . . 155
5.5.5 Disposal of Pesticide Wastes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157
iv
5.6 OCCUPATIONAL HEALTH . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161
5.6.1 Safety/First Aid Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161
5.6.2 Health Examinations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 162
5.6.3 First Aid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 162
5.6.4 Safety and Security in Plants/ Plantations/ Pest Control
Establishments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 162
Chapter 6 POST REGISTRATION ACTIVITIES 164
6.1 GENERAL INFORMATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 165
6.2 MONITORING ACTIVITIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 165
6.3 COMPLIANCE IN MONITORING OF PRODUCT STEWARDSHIP . . . . . . . . 166

6.3.1 Monitoring of Product Quality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 166
6.3.2 Residue on Food and Feeds . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 166
6.3.3 Environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 166
6.3.4 Pesticide Poisoning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 166
6.3.5 Use Patterns . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 167
6.4 PESTICIDE RESIDUES (MRL ESTABLISHMENT) . . . . . . . . . . . . . . . . . . . . 167

6.4.2 Guidelines for Establishing MRLs . . . . . . . . . . . . . . . . . . . . . . . . . . . . 168
6.4.3 Exemption from the Requirement for a MRL . . . . . . . . . . . . . . . . . . . 172
6.4.4 Petition to Change Existing MRLs . . . . . . . . . . . . . . . . . . . . . . . . . . . 172
6.4.5 Crop Groupings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 172
6.4.6 Proposed MRLs for the Philippines . . . . . . . . . . . . . . . . . . . . . . . . . . . 172
6.5 INSPECTION OF HANDLERS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 173
6.6 IMPORTATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 173
6.7 STORAGE AND DISPOSAL OF BANNED PESTICIDES . . . . . . . . . . . . . . . 174
6.8 DATA COLLECTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 174
6.9 TRAINING AND EDUCATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 175
Chapter 7 PENALTIES FOR VIOLATIONS 176
7.1 PRE-REGISTRATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 177
7.2 GROUNDS FOR REVOCATION OF LICENSE . . . . . . . . . . . . . . . . . . . . . . . 177
7.3 POST-REGISTRATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 178
7.4 ENFORCEMENT OF ACTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 178
v
Chapter 8 MISCELLANEOUS PROVISIONS AND REQUIREMENTS 179
8.1 STOCKS OF ANTIDOTES AND FIRST AID SUPPLIES

AND EQUIPMENT FOR CERTAIN PESTICIDES . . . . . . . . . . . . . . . . . . . . . 180
8.2 INSPECTION OF BOOKS AND RECORDS . . . . . . . . . . . . . . . . . . . . . . . . . 180
8.3 PROHIBITED ADVERTISING PRACTICES . . . . . . . . . . . . . . . . . . . . . . . . . . 182
8.4 PESTICIDE PRICING POLICY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 183
8.5 TECHNICAL REVIEW/EVALUATION OF REGISTERED

PRODUCTS FOR POLICY ACTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 183
GLOSSARY OF TERMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 187
vi
LIST OF FIGURES
Figure 1 Schematic Diagram of the Pesticide Product Registration

Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Figure 2 Relationships Among Conventional Pesticides, Biological

Control Agents and Biorational Pesticides . . . . . . . . . . . . . . . . . . . . . . . 66
Figure 3 Environmental Fate Testing Scheme . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
vii
LIST OF TABLES
Table 1 Schedule of Revised Fees and Charges For Pesticide Product

Registration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Table 2 Data Requirement for the Registration and Experimental

Uses of Pesticide Products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
Table 3 Classification of Pesticides Based on Toxicity and Hazard . . . . . . . . . . 62
Table 4 Recommended Positions and Type Size of Information

on the Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Table 5 Summary of Data Requirements for the Registration of

Biorationals (Biochemical Pest Control Agents) . . . . . . . . . . . . . . . . . . . . 97
Table 6 Summary of Data Requirements for the Registration of

Biorationals (Microbial Pest Control Agents) . . . . . . . . . . . . . . . . . . . . . . . 101
Table 7 Summary of Data Requirements for EUP Biorationals . . . . . . . . . . . . . . 106
Table 8 Methods of Detecting Effects of Microbial Pest Control

Agents in Safety Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108
Table 9 Schedule of Revised Fees and Charges for Accreditation/Licensing of

Pesticide Handlers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 124
viii
LIST OF ANNEXES
Annex I Appendix A, Annexes 1 and 2 of the Manual on the

Development and Use of FAO Specifications
for Plant Protection Products Fifth Edition . . . . . . . . . . . . . . . . . . . . . . . 194
Annex II FAO Specifications (sample) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 201
Annex III FPA Bioefficacy Protocol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 208
Annex IV Labelling Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 232
Annex V Labelling of Household Pesticides . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 236

.
Annex VI Good Laboratory Practice in Pesticide Residue Analysis . . . . . . . . . . . . 239
Annex VII Prescribe Application Forms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 251
Annex VIII Risk Appraisal Checklist for “Good Housekeeping

Compliance Certificate” . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 276
Annex IX List of Banned and Restricted Pesticides . . . . . . . . . . . . . . . . . . . . . . . . 279
Annex X Additional Circulars on Restrictions of Specific

Pesticide Products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 284
Annex XI Crop Groupings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 291
Annex XII Reporting of Handlers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 306
Annex XIII FPA Manual on Occupational Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . 311
ix
x
FOREWORD
The current Philippine pesticide policy highlights the need to assure the
agricultural sector of adequate supplies of pesticides at reasonable prices. This is part
of the mandate of the Fertilizer and Pesticide Authority (FPA) as governed by
Presidential Decree 1144. The mandate of protecting the public health and eliminating
environmental risks inherent in their use and of educating the agricultural sector on the
use of the inputs have been an integral part of FPA’s major activities.
This latest revision of the Philippine pesticide policy is in conjunction with the
FPA’s desire to incorporate latest developments in pesticide legislation, policies and
guidelines to safeguard human health and the environment. This final output is the
result of the series of meetings, including consultations with the different stakeholders.
The lessons learned from the past especially on registration procedures and
requirements have been the bases of several changes in this guideline.
Regulatory activities are still considered to be the most feasible and practical
option for ensuring a balance between the benefits and risks of pesticide use in
developing countries like the Philippines. The revised policies aim to do just that. These
proposed policies, however, would be meaningful only if the following requisites are in
place: a proper structure for effective regulation; a responsible pesticide industry; and an
educated populace.
xi
xii
PREFACE
The first guidebook on “FPA Pesticide Regulatory Policies and the Implementing
Guidelines and Procedures “ came out in October, 1985. After about ten (10) years of
implementation, a number of problems had cropped up concerning the practicability
and/or ambiguity of some of its provisions, certain difficulties encountered by the
Authority in pursuing its mandate, as well as in coping with the rapid changes and
development in the pesticide industry. In the main context these provided the reasons for
the revision and updating of this document.
This revised edition of the guidebook, now simply entitled “ FPA PESTICIDE
REGULATORY POLICIES AND IMPLEMENTING GUIDELINES”, not only reorganized
the different topics covered in the first edition, but also included new topics such as the
fast developing group of biorational pesticides and the principle of product stewardship
and responsible care. The first chapter deals with the mandate and structure of the
Fertilizer and Pesticide Authority. Chapter 2 integrates all the rules and regulations
pertaining to chemical pesticides registration including all the data and information
requirements. Chapter 3 is devoted to biorational pesticides to highlight its emerging
importance, while Chapter 4 discusses licensing requirements for pesticide handlers.
Chapter 5 is devoted to product stewardship and responsible care which includes the
guidelines on formulation, packaging, labeling, transport, storage, and disposal.
Similarly, Chapter 6 lumps the monitoring and regulation of post-registration activities
which includes pesticide residue concerns, health and environmental aspects, handler’s
inspection, etc. The last two chapters deal with penalty provisions for violations of any
policy and rules of the Authority and miscellaneous provisions and other concerns not
covered in the preceding chapters.
This document is intended as a guide for all pesticide handlers in their

registration requirements and operational activities in the Philippines. The over-riding
objective is to streamline and make more practical the regulatory process inline with
basic principles and international guidelines contained in relevant documents issued by
FAO, WHO and US-EPA. Additional groups likely to be interested in this guidebook are
other government agencies, environmentalists, academics, and NGOs.
The revision of the guidebook took two stages, a preliminary phase that involved
the critical review and analysis of its contents, identifying the weaknesses and gaps and
areas that needed updating. The second phase involved the actual revision and rewriting
of the guidebook based on the results of the first phase review; as well as the comments
and suggestions obtained from a series of consultative workshops. These workshops,
which were conducted in various parts of the country, were attended by members of the
pesticide industry, pesticide users and other stakeholders.
The adhoc Pesticide Policy Review Committee tasked to revise and update the
guidebook was composed of technical specialists which included Dr. Romulo G. Davide
(Plant Pathologist), Dr. Fernando F. Sanchez (Entomologist), Dr. Nelia-Cortes Maramba
(Toxicologist), Dr. Carlito R. Barril (Environmental Chemist), Dr. Amelia W. Tejada
(Pesticide Chemist), Dr. Agnes C. Rola (Resource Economist), Mr. Ricardo T. Deang
(Entomologist), and Dr. Dario C. Sabularse (Biochemist).
xiii
xiv
Chapter 1
MANDATE AND STRUCTURE OF THE

FERTILIZER AND PESTICIDE AUTHORITY
PERTAINING TO PESTICIDE REGULATION
1.1 MANDATE AND FUNCTIONS OF THE FERTILIZER AND PESTICIDE
AUTHORITY
Created under Presidential Decree No. 1144 on May 30, 1977, the
Fertilizer and Pesticide Authority (FPA) is a technically-oriented agency
mandated to regulate and ensure safety in the manufacture, formulation,
importation, distribution, storage, sale, transport, use and disposal of pesticides
and fertilizers to ensure their adequate supply among crop growers and other
end-users to support the food security program of the country. It is also
mandated to develop both the fertilizer and pesticide industries.
Specifically, to ensure the safe use of pesticides and protect human and
animal health and the environment from any detrimental effects of pesticides,
FPA is vested with the following powers and functions, as described in Section 6
(I) and (III) of PD 1144;
“I. Common to Fertilizers, Pesticides, and Other Agricultural

Chemicals
1. To conduct information campaign regarding the safe and

effective use of these products;
2. To promote and coordinate all fertilizer and pesticides

research in cooperation with the Philippine Council for
Agriculture and Resources Research and other appropriate
agencies to ensure scientific pest control in the public
interest, safety in the use and handling of pesticides,
higher standards and quality of products and better
application methods;
3. To call upon any department, bureau, office, agency or

instrumentality of the government, including government-
owned or controlled corporations, or any officer or
employee thereof and on the private sector, for such
information or assistance as it may need in the exercise of
its powers and in the performance of its functions and
duties;
4. To promulgate rules and regulations for the registration

and licensing of handlers of these products, collect fees
pertaining thereto, as well as the renewal, suspension,
revocation, or cancellation of such registration or licenses
and such other rules and regulations as may be necessary
to implement this Decree;
5. To establish and impose appropriate penalties on handlers

of these products for violations of any rules and regulations
established by the FPA;
2
6. To institute proceedings against any person violating any
provisions of this Decree and/or such rules and regulations
as may be promulgated to implement the provisions of this
Decree after due notice and hearing;
7. To delegate such selected privileges, powers or authority

as may be allowed by law to corporation, cooperatives,
associations or individuals as may presently exist or be
organized to assist the FPA in carrying out its functions;
and
8. To do any and all acts not contrary to law or existing

decrees and regulations as may be necessary to carry out
the functions of the FPA.
xxxx xxxx xxxx
III. Pesticides and Other Agricultural Chemicals
1. To determine specific use or manners of use for each

pesticide or pesticide formulation;
2. To establish and enforce tolerance levels and good

agricultural practices for use of pesticides in raw
agricultural commodities;
3. To restrict or ban the use of any pesticide or the

formulation of certain pesticides in specific areas or during
certain periods upon evidence that the pesticide is an
imminent hazard, has caused, or is causing widespread
serious damage to crops, fish or livestock, or to public
health and environment;
4. To prevent the importation of agricultural commodities

containing pesticide residues above the accepted
tolerance levels and to regulate the exportation of
agricultural products containing pesticide residue above
accepted tolerance levels;
5. To inspect the establishment and premises of pesticide

handlers to insure that industrial health and safety rules
and anti-pollution regulations are followed;
6. To enter and inspect farmers’ fields to ensure that the

recommended pesticides are used in specific crops in
accordance with good agricultural practice;
7. To require if and when necessary, of every handler of

these products, the submission to the FPA of a report
stating the quantity, value of each kind of product
3
exported, imported, manufactured, produced, formulated,
repacked, stored, delivered, distributed, or sold; and
8. Should there be any extraordinary and unreasonable

increases in prices, or a severe shortage in supply of
pesticides, or imminent dangers or either occurrences, the
FPA is empowered to impose such controls as may be
necessary in the public interest, including but not limited to
such restrictions and controls as the imposition of price
ceilings, controls on inventories, distribution, and transport,
and tax-free importations of such pesticides or raw
materials thereof as may be in short supply.”
1.2 ORGANIZATIONAL STRUCTURE
Structurally, the powers and functions of FPA is vested and exercised by

a Board of Directors with the Secretary of Agriculture as Chairman of the Board.
It has eight members who are mostly members of the Cabinet of the President of
the Philippines like the Secretary of Finance, Secretary of Trade and Industry,
Governor of Bangko Sentral ng Pilipinas, and others.
Administratively, FPA is run by an Executive Director/Administrator who is

assisted by two Deputy Executive Directors/Deputy Administrators and other
subordinate officials. The FPA is empowered to determine and create its
organizational structure in order to achieve its objectives, including the number,
positions and salaries of its officers and employees.
In pursuing its mandates on pesticide regulation, FPA has established a

pool of scientists and technical consultants in various aspects of pesticide
regulations like pesticide manufacture, registration, licensing, and others. FPA
created the Pesticide Policy and Technical Advisory Committee (PPTAC). The
Committee is a recommendatory body, which can be assigned to study various
issues and problems related to pesticide regulation and other matters. PPTAC
Members are recognized scientists/experts in their professional fields. These
include Entomologists, Plant Pathologists, Nematologists, Weed Scientists,
Mammalian Toxicologists, Occupational Health and Safety Specialists,
Environmentalists (Ecologists), Residue Chemists, Food Development
Specialists, Economists, and others.
Aside from PPTAC, FPA has also created a group of Pesticide

Registration Consultants (PRC) to specifically study and evaluate
scientific/technical data on pesticides submitted for registration. To address the
growing concern on pesticide residue on food, feeds, and the environment, FPA
formed the Committee on Pesticide Product and Residue Assessment Program
(CPPRAP) to work on residue monitoring, laboratory networking, and the
development of protocol for laboratory accreditation. As the need arises, FPA
can also create study committees, ad hoc committees and sub-committees to
address specific problem areas in pesticide regulation.
4
Chapter 2
REGISTRATION OF CHEMICAL PESTICIDES
5
2.1 GENERAL INFORMATION
2.1.1 Legal Basis
Pursuant to Section 9 of PD 1144 and Article II, Sec. 1 of FPA

Rules and Regulations No. 1, Series of 1977, all pesticides intended for
commercial use in the Philippines shall be registered with the Fertilizer
and Pesticide Authority.
“x x x x Separate registrations shall be required for each

active ingredient and its possible formulations in the case
of pesticides ……x x x x” (Section 9, PD 1144).
“No pesticide shall be imported, manufactured, formulated,

repacked, distributed, delivered, sold or offered for sale,
transported, delivered for transportation, or used unless it
has been duly registered with the Authority or covered by a
numbered provisional permit issued by the Authority for
use in accordance with the conditions stipulated in the
permit. Separate registration shall be required for each
brand and formulation of pesticides” (Article II, Sec. 1,
FPA Rules and Regulations).
2.1.2 Pesticide Definition
Considering the definition stated in PD 1144, the term pesticide

means any substance or product, or mixture thereof, including active
ingredients, adjuvants and pesticide formulations, intended to control,
prevent, destroy, repel or mitigate directly or indirectly, any pest. It shall
be understood to include insecticide, fungicide, bactericide, nematicide,
herbicide, molluscicide, avicide, rodenticide, plant regulator, defoliant,
desiccant and the like.
2.1.3 Purpose of Registration
The purpose of the registration system is to ensure that pesticide

products meet the prescribed standards before they are imported,
manufactured, formulated, distributed and sold in the Philippines.
The standards are set by the FPA and cover the following
aspects:
1. Quality and suitability of the active ingredient and of the formulated

products
2. Bioefficacy
3. Safety to handlers
4. Safety to consumers or users
5. Safety to the environment
6
6. Handling, packaging, labelling and disposal
The system is a stringent process of evaluation with the end point

that benefits outweigh the risks in the use of the product.
2.1.4 Classification of Pesticides for Registration Purposes
For purposes of registration, pesticides are grouped based on

their nature and use pattern.
A. Chemical Pesticides
1. Agriculture/Home Garden/Turf Use
a. Insecticide
b. Fungicide
c. Herbicide
d. Rodenticide
e. Avicide
f. Nematicide
g. Bactericide
h. Molluscicide
i. Acaricide (miticide)
j. Piscicide
2. Household Use
a. Insecticide (including termiticide)

b. Rodenticide
c. Wood Preservative (furniture)
3. Other Chemical Pesticides

(used as is or in combination with others in the formulation)
a. Growth regulator
b. Defoliant
c. Desiccant
d. Systemic activator of Resistance
e. Wood preservative
f. Surfactant/Adjuvant
g. Emulsifier, wetting agent, penetrant, synergist
h. Manufacturing/Intermediate products
B. Biorational Pesticides
1. Biochemical pest control agents
a. Semiochemical (pheromone, kairomone, allomone)

b. Hormone
7
c. Natural plant regulator (Auxin)
d. Enzyme
2. Microbial pest control agents
a. Bacterium
b. Fungus
c. Protozoa
d. Virus
2.1.5 Types of Products to be Registered
The types of products to be registered include the following:
A. New End Use Products or Formulation
This type of application includes the following:
1. New End-Use Product or Formulation Containing new or currently

registered active ingredient.
2. New End-Use Product or Formulation Combination products

containing:
a. New active ingredients and currently registered active

ingredients
b. Currently registered active ingredients
B. Modification in the Registration of a Registered Product
A Material Safety Data Sheet (MSDS) shall be submitted if the

modification involves the potential occupational health and safety
hazards.
Modification of registration covers any of the following:
1. Extension of use or claim

2. Change in rate, timing or frequency of application
3. Amendments to establish Maximum Residue Limit
4. Change in withholding period or pre-harvest interval
5. Change in method of application
6. Change in inerts (solvents and surfactants) in a formulation
7. Change in percentage active ingredient in formulation
C. Registered Pesticides with Changes in Formulation
Change in percentage of active ingredient that will necessitate

a corresponding change in the existing registered dose shall require
submission of bioefficacy data. Changes in solvents and surfactants
8
and type of formulation shall require MSDS, specifications and
bioefficacy data if necessary, upon proof that the change will not bring
about phytotoxicity.
D. New Technical Grade Active Ingredient or a New Source
If there is a change in the manufacturing process resulting in

the change of concentration of a registered active ingredient of the
technical grade, the concerned company shall notify FPA of the
amendment of registration.
If there is a change in the source of a registered technical

grade active ingredient, the new source shall be registered.
E. Permit for an Off-Label Use of Pesticide
Permit may be sought for use of an unregistered product or

use of a registered product other than indicated on the label in
emergency cases such as pest outbreaks or disease/epidemic or
when important, minor use arises where the cost of registration would
exceed economic return to the registrant.
Application for an off-label use permit shall be evaluated on its

merit based on the information submitted and may be granted for the
duration of the emergency period or a period of one year for minor
uses to generate efficacy data for label expansion.
Off-label use permit may be amended or withdrawn by FPA in

case the particular minor use has caused adverse health,
environmental or efficacy implications.
2.1.6 Types of Registration Granted
There are two types of registration granted: full and conditional.
A. Full Registration is granted when the applicant has satisfactorily

completed all the requirements regarding bioefficacy, protection of
the environment, safety to humans and animals. A certificate of
registration is issued to the applicant.
B. Conditional Registration is granted upon satisfaction of the

minimum requirements or conditions as described below. A status
report of conditional registration with the product registration
number is issued to the applicant. Registration is granted but
without quantity restrictions. Stipulations to be met and a
schedule must be agreed to by the applicant as a condition for
registration.
9
If there are gaps in data such as the long-term studies, but
interim progress reports are available, registration shall be granted
subject to an agreement to complete the studies and on their
acceptability in terms of quality and indication of safety. Other
conditions, such as limiting the quantity of importations of the
product or areas to be treated, may be imposed as well.
For new proprietary product being registered which merited

conditional registration status, health monitoring and exposure
study shall be conducted on a case-to-case basis, depending on
the use pattern and dermal toxicity of the product.
Foreign data can be submitted, and if not available,

assessment of exposure risk based on established calculation
model can be submitted to support registration.
Conversion to Full Registration. A conditional registration

may be converted into a full registration within one year when
conditions and requirements have been met satisfactorily. No
renewal/extension of conditional registration shall be granted
except in cases of force majeure or fortuitous events and/or where
the efficacy trials of other tests require a devotion of more than
one year.
Failure to meet requirements agreed upon for a

Conditional Registration is a ground for suspending the
registration.
2.1.7 Miscellaneous Regulations
FPA may register commodity products on another registrant’s data

or on the basis of international reviews (after data protection period)
provided the product is identical or substantially similar to any currently
registered pesticide, or differ only in ways that would not significantly
increase the risk of unreasonable adverse effects. This determination
involves an examination of the registrant’s product and a comparison with
the composition of currently registered products. Appendix A, Annex 2, of
the FAO Manual on Development and Use of FAO Specifications for
Plant Protection Products (Annex I) will serve as a guide for comparison.
The registration of pesticides belonging to toxicity Category I is

presently suspended pending further review. Toxicity/Hazard Category I
has an acute oral LD50 (rat) of 50 mg/kg body weight or less for solid and
200 mg/kg b.w. or less for liquid and a dermal LD50 (rat) of 100 or less for
solid and 400 mg/kg b.w. or less for liquid, based on FPA Memo Circular
No. 03, Series of 1988.
10
Pesticides belonging to this category not covered by the
moratorium nor banned but with existing approved registration and uses
with FPA cannot be expanded on their usage or increase the number of
registration owners. However, further bioefficacy test shall be required if
the objective is to reduce the final spray concentration usage and the
amount of active ingredient per hectare.
After registration consultants review the data, new application for

registration of pesticides belonging to toxicity/ hazard Category II shall be
subjected to further evaluation by PPTAC.
Registration of less toxic and environment-friendly chemicals and

biorational pesticides is being encouraged.
For purposes of these guidelines all provisional registrations

granted to pesticides on or before the promulgation of PD 1144 in May
1977 are revoked and no new provisional registration shall be granted.
FPA reserves the right to suggest a change in the name of the

pesticide product before registering it or before renewal of registration.
Phase-out period for questionable trade/brand name shall coincide with
the three (3) year validity period of a product registration. Use of different
trade/brand name for pesticide product with exactly the same formulation
for the same usage by the same registrant shall not be allowed also.
Naming/Branding of Pesticide Products
Trade name of a pesticide product acceptable for registration

shall:
A. not be misleading to the public;
B. not be the same as other toxic products as certified by Bureau of

Trade;
C. not be the same as any food item;
D. not be offensive to any cultural group; and
E. not misrepresent something.
Registration of Mixtures of Two or More Pesticides
Mixtures of pesticides shall be registered in the same manner as

any pesticide product. The evaluation, however, including the number
and types of allowable combinations of active ingredients, shall be on a
case-to-case basis, with particular emphasis on toxicological and efficacy
considerations. In addition, the following specific conditions shall apply:
11
A. The following mixtures shall not be allowed:
1. Fertilizer and pesticide combinations. While these

formulations ostensibly cut down on the labor input for
application, it may also encourage the unnecessary use of
a pesticide.
2. Mixtures of different types of pesticides e.g. insecticides +

fungicides; herbicides + fungicides, etc.
B. Valid comparative field trials must prove significantly increased

efficacy of the mixture over each of the individual components.
C. In addition to the toxicity data for each individual active ingredient,

acute toxicological data for the mixture as well as potentiation
studies may be required.
2.2 APPLICATION FOR REGISTRATION
Any person, juridical or individual, may file an application for registration

of a pesticide which must be in the prescribed form containing all the data and
information prepared under oath. The proprietary nature of the data shall be
protected by the FPA.
Only local companies registered by the Securities and Exchange

Commission (SEC) to do business in the Philippines and duly licensed by FPA
may apply for registration of pesticide products. For purposes of these
guidelines, a local company is a juridical person created under the Philippine Law
and licensed to do business in the country. Companies operating in the
Philippines under PD 218 are excluded in this definition. Foreign suppliers or
companies registered under the SEC as regional liaison offices (PD 218) are not
allowed to register products. In practice, the applicant or registrant shall be the
distributor or the local subsidiary of a foreign-based pesticide company.
2.2.1 Procedure
A separate application shall be filed for each formulated product

and active ingredient as well as for each source of the active ingredient.
When a formulation has two or more active ingredients, registration shall
be applied for each active ingredient. Only one source of active
ingredient shall be applied/approved at a time.
A complete application, submitted in duplicate (except for No. 1

which shall be submitted in triplicate) consists of:
1. Form for Registration of an Active Ingredient (P-012), Registration

of a Pesticide Product (P-022)/and Source of Active Ingredient (P-
032).
12
2. Complete data required to support registration particularly Table 2.
on Data Requirements, with a certification that they comply with
good laboratory practices (GLP) and standard test protocols.
3. Summary of data with proper citation and an applicant’s

assessment of how these data support registration.
4. Proof of registration in other countries where relevant.
5. Dummy label and labelling text.
6. A sample of the material to be registered shall be submitted prior

to registration. The following must accompany an application: 1 g
Analytical Grade of the Active Ingredient(s), 10 g. Technical Grade
material; and 500 mL or 0.500 Kg of the formulation. The
percentage purity of the technical grade and the method used to
determine purity should be provided. Information on the shelf life
of the analytical and technical grades should be submitted
together with the Material Safety Data Sheet and Certification of
the origin of samples. Samples submitted to FPA shall be stored
and handled properly for future needs of government institutions.
7. Certificate of analysis of active ingredient, both analytical grade or

technical material, and the formulated product.
8. Reviews of data done by other countries and international

organizations especially US-EPA and European Union if available.
9. Any authorization necessary to cite previously submitted data.
10. Data must be submitted in size 81/2 x 11 paper or A4, indexed

and bound separately, i.e. one folder each for the following sets of
data with table of contents: Specifications; Bioefficacy;
Toxicology; and Residues/Environmental Fate. The dummy label
shall appear as the first entry in each folder. The specifications
shall also be submitted in each of the folders for Bioefficacy,
Toxicology and Human Exposure and Safety, and
Residues/Environmental Fate & Transport/Environmental Effects.
Copy of approved Experimental Use Permit(s) (EUPs) shall be
included in the Bioefficacy folder. Any additional data required
shall also be submitted as prescribed. Submissions that do not
follow these requirements shall not be accepted.
Filing fee for each active ingredient/pesticide product shall be paid

upon submission of the application.
13
2.2.2 Steps In Processing An Application
All applications received shall be screened for completeness by

the designated Registration Coordinator within one (1) week. If found
incomplete, it will not be processed but returned to the applicant. The
complete application shall then be entered into the registration tracking
system and the applicant shall be notified.
The complete data sets shall be sent to the respective consultants

for evaluation/assessment. For commodity products, the maximum time
for evaluation shall be three (3) months. For proprietary products,
simultaneous evaluation of specifications, bioefficacy and residue/fate in
the environment shall be three (3) months while that of toxicology will be
nine months.
Consultants’ evaluation reports shall be consolidated and

reviewed by FPA within a period of three (3) weeks. If the evaluation is
satisfactory, notice of approval of registration shall be sent to the
applicant.
If the evaluators have some questions on the data submitted or

require other information on the product, a status report or registration
indicating these concerns shall be sent to the applicant. The applicant
shall be given reasonable time to resubmit these information.
Resubmitted data shall be sent to the original reviewers for evaluation
whenever possible.
Products of hazard Category II pesticides or those that have

questionable data or issues which the evaluator recommended for further
review is referred to PPTAC for resolution.
The steps in processing application for EUP and registration are

presented in Figure 1.
2.2.3 Estimated Timetable for Review Process
A. Commodity Products
Final registration status report shall be made available in

three (3) to six (6) months after submission. During this period, an
evaluation status report or an interim report shall be given to the
applicant after one month from date of submission.
14
Figure 1. SCHEMATIC DIAGRAM OF THE PESTICIDE PRODUCT
REGISTRATION PROCESS
Applicants FPA Checks

Submits Documents
Documents
Data
FPA
Complete
No
Consultants Yes
Review/Assess
Data
Data
No
Yes
FPA Integrates
Consultant’s
Reports
Yes
Accept
No
For CAT II or
questionable
Data
PPTAC
Recommends
Full
Yes
Accept Recommend
No Registration
Conditional
15
B. Proprietary Products
Two sets of procedures shall be followed depending on

whether these products are (1) currently registered in the
developed countries (USA, Germany, Japan, etc.); or (2)
registered and commercialized in the region as per FAO
guidelines.
For products in the first case, final registration status report

shall be made available within twelve (12) months after
submission. During this period, a quarterly evaluation report or an
interim report shall be provided to the applicant.
For products in the second case, final registration status

report shall be made available within six (6) months after
submission. During this period, an evaluation status report or an
interim report shall be given to the applicant after three (3) months
from date of submission.
In other cases, status shall be available within one (1)

month after receipt of application.
Applicant shall be given an opportunity to submit any

additional information relevant to the problems at this stage. If
FPA believes that the issues may be resolved through a
replacement study, the application shall be referred back to the
initial reviewer/evaluator.
If the results indicate significant scientific or technical

issues, the applicant shall be notified of the problem and of the
proposed method of resolution, e.g., PPTAC referral,
management policy review, consultation with other registering
countries or international review group(s). These issues shall be
communicated to the registrant in an evaluation status report after
which the registration time for the product is stopped. Registration
time is resumed after the applicant has resubmitted data resolving
the problems/issues raised by the registration
consultant/evaluator.
Problems/issues involving critical decisions may be

referred to the PPTAC for review. When this referral is made, the
applicant shall be advised of the status within forty five (45) days.
A report of the review shall be provided to the applicant whenever
appropriate.
FPA shall prepare a status report every three (3) months

on the basis of the Registration Tracking System and shall be
stated in terms of the following:
16
1. In-progress with evaluators/reviewers/PPTAC;
2. Needing replacement/additional data; and
3. Application denied specifying the reasons. Deficiencies or

other reasons for denial shall be communicated.
Note: The applicant may apply for reconsideration.

Submission of required data shall be within six (6) months
after receipt of the official denial. Otherwise it shall be treated
as a new application.
2.2.4 Period of Validity and Renewal of Registration
Pursuant to Art. II, Sec. 6 of the FPA Rules and Regulations, each
registration shall be valid for a period of three years, unless earlier
revoked or cancelled.
Renewal of registration may be filed three (3) months before its

expiry date by paying the appropriate fees and submitting two (2) copies
of notarized application form, Material Safety Data Sheet and label.
Application for renewal filed within one (1) month after expiry date
of its registration shall be subjected to 50% surcharge while those filed
after the said period shall be subjected to a 100% surcharge. Similarly, a
separate application for renewal shall be filed for each formulated product
and active ingredient.
2.2.5 Re-Registration and Renewal Requirements
A. When warranted by occurrence of the development of resistance,

unacceptable levels of residue in the field, or other toxicological
concern, a registered product shall be reviewed for purposes of
re-registration/renewal. The registrants shall be required to
conduct monitoring studies on product performance, supervised
residue field trials and/or submit the required toxicological data to
FPA.
B. If registration of the product is not renewed, sale shall be stopped

immediately and the product shall be recalled within six (6)
months at the expense of the registrant.
2.2.6 Fees
Fees for filing registration, resubmission, and renewal are

indicated in Table 1 and the same shall be subjected to review from time
to time.
17
2.2.7 Maintenance of Official FPA Lists of Registered Products and Uses
FPA will maintain a “List of Registered Products” which will be

updated and released quarterly for use by field coordinators. FPA will
also maintain an updated “List of Registered Use Pattern.” These lists
will be available to others upon request.
2.3 DATA REQUIREMENTS FOR REGISTRATION AND EXPERIMENTAL USE

PERMIT
2.3.1 General Information
This Section spells out the data that must be submitted with an
application for registration or Experimental Use Permit (EUP). The data
requirements are specified based on whether the product is a formulation
or an active ingredient and whether it is for agricultural or household use.
The data required for an EUP is a sub-set of the requirements for
registration and these are indicated in Table 2 which summarizes these
data requirements.
Special circumstances often arise from the nature of a pesticide or

its use or the results of testing which dictate whether more, less, or
different data are required. FPA shall make modifications whenever
appropriate and necessary.
All data shall be of sufficient scientific quality and reliability to

answer questions of safety and efficacy without doubt or uncertainty.
Studies done in compliance with good laboratory practices (GLP) such as
those of OECD, US FDA or EPA and in consonance with acceptable test
protocols shall stand the best chance of meeting the standard. Deficient
or invalid studies can be sufficient grounds to deny an application and/or
to require a replacement study. A reference list of acceptable test
protocols is contained in Section 2.10.
Decision on whether or not registration will be granted shall take

into consideration the set of criteria adopted for this purpose.
A. General Applicability and Alternative Means for Satisfying

Requirements
The data requirements are generally applicable to all

registrants for proprietary interest in the product. For commodity
products, data on general information (1.0) and specifications
(2.0) are applicable. The nature of information necessary for FPA
to perform an adequate evaluation is the same in either case.
However, data requirements can be satisfied in a number of ways.
18
Application for commodity pesticides and some proprietary
compounds may be satisfied by citing appropriate reviews of the
relevant data in developed countries or providing results of
international reviews by organizations such as WHO/IPCS or
WHO/FAO JMPR. It can also be done by citing data already
submitted to FPA that do not have proprietary protection.
Although the Philippines has not officially adopted national

standards for specifications of pesticides, FPA shall utilize the
FAO and WHO specifications for pesticides used in agriculture
and public health or household purposes, respectively, as the
minimum standards for registration purposes, particularly of
commodity products. Annex II presents samples of FAO
specifications.
Data on specifications especially for commodity products

introduced from a new supplier shall be authenticated by an
independent laboratory analysis. FPA reserves the right to require
confirmatory analyses done by local laboratories like the National
Pesticide Analytical Laboratory (NPAL) of the Bureau of Plant
Industry (BPI), the Philippine Institute for Pure and Applied
Chemistry (PIPAC), and Industrial Technology Development
Institute (ITDI), or any other laboratory deemed acceptable
through accreditation by the FPA.
Data for determining efficacy usually generated in the

country may, if cases warrant, be extrapolated from similar crops
and pest situations in other countries with similar climatic
conditions or from similar formulations. To merit acceptance of
efficacy data by FPA, it is important that the prescribed FAO test
protocols or other internationally prescribed and accepted
protocols be strictly followed. When the use is in the “List of
Pesticide Registered Use Pattern,” these shall suffice for
commodity pesticide to meet efficacy requirements for registration
of similar subsequent applications.
Acute oral toxicity data on formulations and active

ingredients are required. Many of the environmental fate tests
maybe done with typical formulations extending the range of
applicability to all similar products. Test protocols will generally
specify appropriate test materials, i.e. active ingredient, individual
formulation or a typical formulation.
B. FPA Accepts Third Party Authorizations
From the data owner for another registrant to cite their data
for registration purposes. The following concepts of third party
authorizations should be acceptable to both parties:
19
1. Authorization of this nature is applicable for registration of
products still under proprietary data protection, coming
from the same supplier.
2. Third party Authorization may also be allowed for
commodity products coming from the same supplier.
3. Authorization is only for the use of submitted registration
data. Authorized party shall still comply with other
requirements: filing of application forms, payment of fees,
and submission of technical and analytical grade samples
and labels.
C. Protection of Proprietary Data.

The proprietary nature of the data is protected by FPA.
The patent is not considered by FPA but is an independent
consideration to be resolved among the patent holder, the
registrant or applicant, and the Intellectual Property Office (IPO).
Data submitted to support the first full or conditional registration of
a pesticide active ingredient in the Philippines shall be granted
proprietary protection1 for a period of eight (8) years from the date
of approval of registration. During this period, no subsequent
application for registration may be entertained.
Pesticides granted provisional registration under PD 1144
shall be considered first registered in 1977, the date of the
Decree.
D. Protection of New Data Submitted During the Review or Re-

registration Process
New data (not available in any published literature), which
are submitted as a requirement during the review or re-registration
of any registered compound, shall be given data protection1 for a
period of three (3) years from the date of approval of re-
registration. During the course of this three-year protection, a
certain compound that has been registered or has passed the
review process may turn generic (or whose original 8 year data
protection has lapsed). In such a case, a later registrant may
apply for registration of the same compound on the basis that he
generates/produces and submits the same new or additional data
required from the original registrant as support during the review
or re-registration process as long as the three-year protection of
the new data is in force.
1
The authority of the FPA was sustained by the Regional Trial Court of Quezon City, Branch 90 in SP
Civil Case No. Q-01-42790 entitled, ”Pest Management Association of the Philippines (PMAP) vs. FPA.”
The PMAP appealed the decision of the RTC to the Supreme Court in G.R. No. 156041 and the same is
pending decision.
20
2.3.2 Chemical Pesticides
A. Agriculture/Home Garden/Turf Use
The guidelines and data requirements for the registration

of pesticide products for agriculture are applicable also for
products intended for use in home gardens and parks or golf
courses.
The data requirements are indicated in Table 2 and discussion or

explanatory notes on the required data are presented in Section
2.5.
B. Registration of Pesticides for Household Use
Household pesticide products are intended for use in

domestic or commercial establishments for the control of flying,
crawling and structural insect pests. Household pesticides are
further classified into two categories:
1. Institutional/Pest Control Operator (PCO) Use
These are applied as space spray or surface spray

for knockdown and residual action by or under the
supervision of Certified Pesticide Applicator (CPA). They
are commonly formulated as concentrates in the form of an
EC, WP, Suspension, Encapsulated, etc.
The formulated or end-use product shall be used in

generating efficacy data. Relevant foreign data are
acceptable including bioefficacy.
2. Consumer Use
Household pesticide products are intended for

domestic or commercial establishments used against flying
and crawling insects. These are applied as ready-to-use
space spray or surface spray for knockdown and residual
action. They are commonly formulated as aerosol or as
liquid end-use product applied with manually operated
pressure spray. Other forms include pest strips, baits,
balls and others.
Registration of pesticides for use of household

consumers shall be based on usage and the classification
hazard of the formulation. Only Toxicity Categories III and
IV shall be allowed for registration. In case of mixtures, a
maximum of three (3) a.i. in the formulation is allowable but
its approval is dependent on its merit based on the data
submitted.
21
generating efficacy data. Relevant foreign data are
acceptable because:
a. Conditions are the same (whether temperate or

tropical country).
b. Target species are cosmopolitan.
c. Application technology is the same.
d. End-use rate is the same.
e. Application equipment are the same.
The data requirements for the registration of

household pesticides are indicated in Table 2.
Minimum efficacy data requirement for new end

product with new active ingredient and major formulation
change of a registered active ingredient are as follows:
a. For claim of control of flying and crawling insects
1. Space sprays for flying insects
• A species of flies, preferably Musca

domestica
• A species of mosquitoes, preferably Culex
or Aedes
• Two species of moth, a large and small
moth species
2. Surface sprays for crawling insects
• Two species of cockroaches, Blatella spp.

and Periplaneta spp.
• A flea species, preferably
Ctenocephalides felis
• An ant species
• A species of mites and ticks
b. For claim of control of mice and rats
• A species of mice, preferably Mus spp.

• A species of rats, preferably Rattus spp.

generating efficacy data. Foreign laboratory-generated
data are acceptable supplement but local tests of actual
use are still required whenever allowed by existing
facilities.
22
For commodity household pesticide, foreign data
are generally acceptable for full registration.
C. Registration of Other Chemicals
Data requirements for registration of insect growth

regulator, defoliant, desiccant and wood preservative shall follow
that of pesticides for agriculture.
The registration requirements for plant growth regulator

shall be specifications and biological efficacy only unless the
chemical has been shown to be hazardous or has other uses, in
which case, the compound shall follow the guidelines for
registration of agricultural pesticides.
For the registration of synergist and pheromone, the

requirements are bioefficacy, specifications, MSDS, and acute
toxicity studies.
For surfactant, emulsifier, penetrant, wetting agent,

safener, adjuvant, if used as component of the product
formulation, only specifications and MSDS are required.
However, if used as a lone material, efficacy data, specifications,
MSDS and/or acute toxicity data are required
2.4 EXPERIMENTAL USE PERMITS
Pesticide products, chemicals and biorationals intended for

registration shall be tested for efficacy under local conditions. For field-
testing necessary to generate data for registration purposes or other
uses, Experimental Use Permit (EUP) shall be applied for and under no
circumstance shall the test be conducted without the approved EUP. The
experiment shall be conducted by researchers accredited by FPA
following the standard protocols for biological efficacy testing. Data
submitted without the necessary permit/conditionalities shall not be
accepted for registration.
The EUP limits the amount of pesticide necessary to conduct the

test so as to safeguard the health of direct and indirect users of the
product as well as the environment.
Field trials of tank-mix formulation involving registered products

may be conducted without EUP on the same crop(s) and pest(s).
Unless residue data on the crop where the product will be tested
and a ninety (90) day oral sub-chronic and an interim or full report on one
chronic study are available, crop destruction shall be done in EUPs 1A
and 1B and, if deemed necessary, for EUP II.
23
The FPA Coordinator in the area where the field test will be
conducted shall be provided with a copy of the approved EUP for
monitoring the manner of use of the products, and the observance of the
protection of public health and the environment.
2.4.2 Types of Experimental Use Permits (EUP)
There are four (4) types of EUPs and the appropriate type shall be
applied for each pesticide to be tested per crop per season per location.
1. EUP IA covers coded compounds in the initial stages of

development to be tested only within the company research
station. The applicant shall submit the notice of intent at least two
(2) weeks in advance together with the information and
requirements indicated in Table 2. A notice of approval shall be
sent within fifteen days from the receipt of notification of intent.
2. EUP IB covers coded compounds to be tested outside the

company research station but on a limited area. It has the same
requirements and conditionalities as EUP IA.
3. EUP II covers those pesticides, coded or branded in the pre-

market stage and the bioefficacy data generated may be used for
registration purposes. The EUP application requires prior
approval before conducting the test because of the larger number
of potentially exposed individuals and broader environmental
exposure.
4. EUP III covers registered pesticides to be tested for additional

uses or for label expansion. Advance review and approval shall
be required if a registered pesticide is to be tested on a new crop
or when hazard is increased wherein higher dose is tested on
previously registered crop use.
No EUP is required in situations where the crop and pest uses are
registered and the dose to be tested is lower than the registered dose and
frequency, thereby, no increase is expected in hazards or crop residue.
2.4.3 Application
The applicant or registrant shall accomplish the relevant

application form e.g. Notice of Intent to Conduct Experiment (P-001) or
Application Form for Experimental Use Permit (P-002) in triplicate and
submit these together with the data required.
Application shall be filed at least three (3) months prior to the start
of the experiment for EUP II and III and two (2) months for EUP IA and IB
to facilitate review of the application. Status of the application shall be
issued not later than one (1) month before the stipulated start of the
experiment.
24
Filing fees for all EUPs shall be paid upon submission of
application (Table 1).
2.4.4 Data Requirement
The data required in support of the application for EUP for

chemical pesticides are indicated in Table 2.
2.4.5 Validity and Extension
An EUP for a pesticide is valid for one crop for the required
number of seasons and locations. The period of coverage for an EUP
maybe extended upon request and payment of application fee (see Table
1) provided the reasons are acceptable to the FPA.
2.5 EXPLANATORY NOTES ON TYPES AND USE OF REQUIRED DATA
2.5.1 Test Substance
The registrant shall be careful to distinguish what are required in

Table 2 and what substance is to be tested. The test protocols generally
provide information on the test substance.
2.5.2 Identification of Registrant, Product and Manufacturing Process
This is basic administrative and background data. A brief

description of the manufacturing process supported with a simple flow
chart plus a few paragraphs of description shall be submitted. The intent
is to understand the basic steps to forecast where impurities or other
undesirable constituents may enter into the product and to compare the
likelihood that the same product produced by two (2) or more
manufacturers will be substantially similar.
2.5.3 Specifications
Specifications are necessary to make sure that the registration

data were produced using a chemical sufficiently similar to that being
proposed for registration; to assure that harmful impurities, etc. are
identified and evaluated as well as limited in the final product; and that the
product as marketed conforms with what is approved for registration.
Data submitted to meet product chemistry requirements include

description of manufacturing process of the active ingredient and the
formulation, information on product composition, and chemical and
physical characteristics of the pesticide.
25
A. Product Composition
1. Data on product composition are needed to support

conclusions expressed in the statement of formula. These
data include information on all the ingredients, on the raw
materials or unreacted starting materials and
manufacturing process, a discussion on formation of
impurities, results of preliminary analysis of product
samples, a certification of ingredient limits, and an
explanation of how the certified limits were determined, the
description of, and the validation data for analytical
methods to identify and quantify ingredients especially
those above 0.1% which may be toxicologically significant.
Any unidentified impurities present shall be considered as
part of the total ingredients. If with special toxicological
significance, materials even below 0.1% shall be declared.
2. Product composition (as indicated in the confidential

statement of formula) is compared with the composition of
materials used in toxicity and bioefficacy tests and other
studies. This comparison indicates which ingredients in a
pesticide product have been evaluated by a particular
study, and might lead to a conclusion that another study is
needed. Based on conclusions concerning product’s
composition, impurities and its toxic properties, appropriate
use restrictions, labelling requirements, or special
packaging requirements may be imposed.
3. Product composition data including the certified limits of

the ingredients are used in the review of applications for
registration.
B. Physical and Chemical Characteristics
1. Data on the physical and chemical properties of active

ingredients and formulated products are used to confirm or
provide supportive information on their identity.
2. Certain information (e.g. color, odor, physical state) is

useful in emergency situations for identification of
unlabelled pesticides involved in accidents or spills.
Physicians and hospitals can use this information to aid in
identification of materials implicated in poisoning episodes.
3. Certain chemical and physical data are used directly in the

hazard assessment. These include stability, oxidizing and
reducing action, flammability, storage stability, corrosion,
etc. For example, the storage stability studies provide data
on change in product composition over time. If certain
26
ingredients decompose, other decomposition products may
be formed whose toxicity and other characteristics need to
be considered.
4. Certain data are needed as basic or supportive evidence in

initiating and evaluating other studies. For example, vapor
pressure data are needed, among other things, in order to
determine suitable re-entry intervals and other label
cautions pertaining to worker protection. Data on viscosity
and miscibility provide necessary information to support
acceptable labelling for tank mix and spray applications.
2.5.4 Bioefficacy Data
Bioefficacy data provide a mechanism to ensure that the pesticide

product will perform as indicated in the label against the intended pests.
It should be generated locally with approved Experimental Use Permit.
FPA-prescribed test protocols for specific crops are attached as

Annex III for guidance. In general, for insecticides, fungicides and other
pesticides, one-season testing in two (2) locations are acceptable for
registration. For herbicides, testing for two (2) seasons on two (2)
locations per season are required.
Bioefficacy data generated in other Asian countries with similar

climatic conditions and following the FAO Test Protocols or any regionally
accepted guidelines developed in the region may be acceptable for the
same crops and pest species/strains existing in the Philippines.
2.5.5 Toxicology Data
A. Test Substance
Under most circumstances, the test substance will be the

technical material produced during the normal manufacturing
process. Under certain circumstances, it may be required that an
analytical pure active ingredient, a contaminant, a metabolite, or
any combination of these be tested. In some cases, data for the
formulation may be required.
B. Acute Toxicity Studies
The data from these studies, as well as the results from

skin and eye irritation and dermal sensitization studies, are used
to identify the relative acute toxicity of the product for classification
and for label precautionary statements. Preliminary information
may also be obtained on the specific toxic effects and the mode of
action of the test product.
27
Acute oral toxicity shall be conducted on rodent for the
active ingredient and for the formulation product. Acute dermal
toxicity shall be conducted on rat, skin and eye irritation on rabbit
and dermal sensitization study on guinea pig for both active
ingredient and formulation.
C. Short-term Studies
These studies delineate the toxic potential of the pesticide

through continuous or daily repeated administration for less than
one-sixth of the life span of the test species. The data obtained
are useful in elucidating such problems as possible cumulative
action, variation in species sensitivity and in identifying specific
organ effects. These studies shall be conducted on the active
ingredient only using rodent for sub-chronic oral and on sub-
chronic dermal.
D. Long-term Studies
These studies provide information on the maximum

dosage level which produces no discernable injury to animals; on
the tumorigenic potential of a pesticide when administered
continuously or daily over the major portion of the life span of the
test animals; and may reveal effects, which are not predictable
from short-term toxicity studies.
Unless other studies indicate otherwise, long-term studies

shall be conducted using the technical grade of the active
ingredient administered by the oral route on rat.
E. Special Studies
In addition to the above studies, the following are also

required:
1. Pharmacokinetic Studies: A good understanding of the

pharmacokinetics of the pesticide shall enable more
judicious selection of appropriate routes of administration
and dose levels in long-term studies, and actual tests
which should be done on the product. Since one of the
purposes of such studies is to aid in the extrapolation of
animal toxicity data to man, studies in multiple animal
models using appropriate species are usually more
meaningful.
2. Mutagenicity Tests may be used to screen mutagenic

potential as well as a pre-screen for carcinogenic potential.
Using in vivo and vitro tests, the limitations of these tests
are realized, but they provide useful information which can
28
be used along with the results from the whole animal
experiments to give some preliminary indication of the
mutagenic and carcinogenic potential of the test product.
3. Studies of Breakdown Products: Toxicity studies on

metabolic and environmental breakdown products may be
necessary to evaluate the potential hazards of human
exposure to such chemicals in food and in treated areas
which must be entered by workers.
4. Teratogenicity Studies shall be conducted on rats and

rabbits for the active ingredient and shall provide data on
the potential of pesticides to produce or alter the incidence
of congenital malformation and functional disorder.
5. Reproduction Studies on Rats provide information on the

potential effects the pesticides might have on the
reproductive capacities of the parental generation from the
mating through lactation and on the offspring from the
conception through lactation and mating. The study shall
be conducted on one (“a”) litter from each of two
generations unless postnatal adverse effects, doubtful
effects on any reproductive parameter, or lack of
stabilization of blood and tissue levels (cumulative
compound) are observed. Then, (“b”) litters shall be
required in at least one generation.
2.5.6 Human Safety
Worker exposure study is required for new proprietary products

under registration with strong toxicological concern. Worker exposure
and safety are generally arrived at by observation or judgement and
monitoring or calculation as pointed out in the data requirements table
(Table 2). Whenever worker exposure studies are conducted, they shall
only be done after there is reasonable assurance that the applicator or
farm worker or test subjects will not be placed at undue risk. To reduce
the cost of conducting such trials, they should coincide with efficacy field
trials.
Worker exposure studies can be very useful in determining the

magnitude of the margin of safety under use conditions. Monitoring data
generated during exposure studies are used to determine the quantity of
pesticide to which people may be exposed after application and to
develop re-entry intervals. Studies on toxicity using animal species and
residue dissipation can also be used to assess hazard to farm workers
and applicators.
29
2.5.7 Environmental Effects
A. General
The information required to assess hazard to non-target

organisms are derived from tests which determine pesticidal
effects on birds, mammals, fish, terrestrial and aquatic
invertebrates, and plants. These tests include short-term acute,
sub-acute, reproduction, simulated field, and full field studies
arranged in a tier system, which progresses from laboratory tests
to the applied field tests. The results of each tier of tests shall be
evaluated to determine the potential of the pesticide to cause
adverse effects, and to determine whether further tests are
required.
B. Short-term Studies
These data are used: 1) to establish acute toxicity levels of

the active ingredient to the test organisms; 2) to assess potential
impacts on fish, wildlife and other non-target organisms; and 3) to
indicate whether further laboratory and/or field studies are
needed.
C. Long-term and Field Studies
Data from these are used to estimate the potential for

chronic effects, taking into account the measured or estimated
residues in the environment. These are also used to determine
whether field or laboratory studies are needed to further evaluate
hazards.
2.5.8 Environmental Fate and Transport
A. General
The data generated by environmental fate studies are

used to assess the following: 1) toxicity to man through exposure
to pesticide residues remaining after application, either upon re-
entering treated areas or from consuming inadvertently-
contaminated food; 2) the presence of widely distributed and
persistent pesticides in the environment which may result in loss
of usable land, surface water, ground water, and wildlife
resources; and 3) potential environmental exposure of other non-
target organisms, like fish and wildlife, to pesticides.
30
B. Degradation Studies
The data from photolysis and hydrolysis studies are used

to determine the rate of pesticide degradation and to identify their
adverse effect on non-target organisms.
C. Metabolism Studies
Data from aerobic and anaerobic metabolism studies are

used to determine the nature and availability of pesticides to
rotational crops and to aid in the evaluation of the persistence of a
pesticide.
D. Mobility Studies
These data pertain to leaching, adsorption, desorption, and

volatility of pesticides. They provide information on the mode of
transport and eventual destination of the pesticide in the
environment. The data are used to assess potential
environmental hazards related to contamination of human and
animal food; loss of usable land and water resources; and habitat
loss of wildlife resulting from pesticide residue movement or
transport in the environment.
E. Accumulation Studies
Accumulation studies indicate pesticide residue levels in

food supplies that originate from rotational crops and bodies of
water. These data allow FPA to establish label restrictions
regarding application of pesticides on sites where residues can be
taken up by crops and edible fish or shellfish.
2.5.9 Residues in Food
Residue chemistry data are used to estimate the exposure of the

general public to pesticide residues in food. Information on the chemical
identity and composition of the pesticide product, the amount, frequency
and timing of pesticide application, and results of tests on the amount of
residues remaining in food, are needed to support findings on the
magnitude and identity of the residues which may be found in food as a
consequence of a proposed usage.
For registration purposes, FPA may allow applicants to submit

residue data generated from other countries with similar agro-climatic
conditions and use patterns following FAO guidelines on Supervised
Pesticide Residue Field Test.
31
2.6 GROUNDS FOR DENIAL OF REGISTRATION
Registration may be denied on any one of the following grounds:
1. False information in the application and data submitted.
2. Product is very hazardous to health based on the proposed use even if

the prescribed precautions are taken to arrest such hazard.
3. Risks are higher over benefits in the use of the product specially when
there are less hazardous registered products existing for the same or
similar purpose.
4. Product is phytotoxic and when plant recovery is minimal to compensate

for crop yield losses.
5. Product is significantly less effective than the reference registered

standard product.
6. Persistence of residues in crops and in the environment such as soil and

water.
7. Potential or proven carcinogen, fetotoxic, teratogenic, mutagenic, and

oncogenic at doses relevant to humans.
2.7 OBLIGATIONS OF REGISTRANTS
Registrant shall maintain and submit to FPA a record of all reported

adverse chemical reaction or effects associated with the use of the product as
directed in the label.
The record shall contain the complainant’s name, address, phone

number, details of the complaint, investigations performed, quantity of products
used, diagnosis and final outcome.
All suspected adverse chemical effects associated with the use of the
product or which have serious implications on health and/or environment shall be
reported immediately to the FPA and followed up with a report of investigation of
the incident.
Any development of resistance to the registered product by a pest or any

unforeseen breakdown in stability shall be reported to the FPA together with the
corrective action taken.
Failure to meet these obligations could result in a fine and a possible

cancellation of registration.
32
2.8 LABELLING REQUIREMENTS
A. Legal Provisions
Article V of the FPA Rules and Regulations No. 1, Series

of 1977, in particular Sections 1 to 4, 6 and 8, describe the basic
requirements for a pesticide label including the prescribed
statements, language, FPA control number, precautionary
measures, and others. Specifically, Sections 1 and 2 summarize
the requirements as follows:
“Section 1. Every container of pesticide offered for

sale, distribution, storage and use shall bear a label
printed, stenciled, marked, embossed or impressed
on or attached to it, which must, among others,
include the following:
a. A statement of the composition by percentage,

including all ingredients and the chemical
identity of the active ingredient(s);
b. The registration or provisional permit number;
c. The name and address of the holder of the
registration or provisional permit;
d. The common name;
e. The net contents, in metric unit, of the pesticide
in the container;
f. Adequate directions concerning manner in
which the pesticide is to be used and time of
application;
g. Warning and cautionary statements including
the symptoms of poisoning and suitable and
adequate safety, health and first aid treatment
measures;
h. A suitable indication of hazard, including the
appropriate pictorial warnings for highly toxic
substances;
i. Instructions concerning the decontamination
and safe disposal of used containers;
j. Such label claims, if any, as have been
accepted by the Authority;
k. The lot number and year of formulation; and
l. Such further statements as may be prescribed
by any other government instrumentality.
Section 2. Each label shall be in English or any of

the major dialects, must be legible and distinct in its
meaning and attached to, printed or affixed on the
33
side of the container in such a way that the whole
content of the label can be read without detaching
the same.
Section 3. No label shall be detached, altered,

defaced, changed or destroyed, in whole or in part,
in a manner that will defeat the purpose of existing
rules and regulations.
Section 4. No substance shall be added to or taken

away from any pesticide earlier labelled in
accordance with the provisions of these rules,
unless properly registered.
xxxx xxxx xxxx
Section 6. A pesticide labelled in accordance with

these rules, which has so decomposed or
deteriorated as to be ineffective or dangerous, or
which package containers have deteriorated or
have been damaged so as to be dangerous in
storage and use, shall not be offered for sale or
distribution.
xxxx xxxx xxxx
Section 8. Any written, printed or graphic material

relating to and accompanying a pesticide when
held, transported, distributed, stored, sold or
offered for sale, used in the country or imported
shall include the substance label statements
prescribed in Section 1 of this Article.”
2.8.2 Purpose of the Label
The purpose of the pesticide label is to provide readily-understood

information on:
1. The content of the container and the purpose(s) for which it may be
used;
2. The direction on how to use the pesticide;
3. The hazard of the pesticide and the appropriate precautions to take in
its storage, handling and use; and
4. The symptoms and signs of poisoning and the recommended first aid
and medical treatment in the event of poisoning. Specific antidotes
and appropriate dosages shall be contained in the labels.
The degree of precautionary labelling shall reflect the assessed

hazards of the product. “Overlabelling” of relatively harmless products
34
may promote the development of a general disregard for precautionary
texts and may defeat the purpose. The following guidelines are intended
to facilitate the implementation of the FPA Rules and Regulations and to
assist in determining the appropriate statements for pesticide labels. If
followed, they shall expedite the registration process. FPA reserves the
right to give additional requirements when necessary.
2.8.3 General Considerations on Labelling
Every label on the container of a pesticide shall be:
1. Clearly printed with each statement in a uniform color against a

white background; letter prints shall however, be in black.
2. Firmly attached to the container and be of such nature that it will

not fade to the extent that it becomes illegible, and will not be
detached through the influence of light, temperature, humidity,
water or the contents of the container.
3. In such a position that it is not damaged or removed when the

container is opened.
All labels shall be in English, unless otherwise specified and

approved by the Authority. However, information on safety and
precautions shall be in both English and Filipino, or any major dialects
such as Cebuano, Ilongo, Ilocano, Bicolano and others. For the smallest
packs (100 mL for liquid) however, only the Filipino version is required.
Text prepared in the form of a leaflet is acceptable as a part of the label.
This shall however be attached to the container without permanently
obscuring the actual label.
With the possible exception of the “Note to the Physician”, all

label statements shall be in plain, understandable language, readily
comprehensible to the layman.
No label of any pesticide shall contain a statement to the effect

that the pesticide is harmless or is non-toxic.
The following sections of the label shall appear in the consecutive

order as follows:
1. Warning;
2. Precautions;
3. Signs & Symptoms of Poisoning;
4. First Aid; and
5. Note to Physician.
The warning and precaution may be highlighted by enclosing in a

rectangular “box” formed by a prominent continuous line.
35
The label must be legible. A minimum type size of six (6) points
for wording on the labels is preferred. FPA has the right to reject illegible
type sizes.
2.8.4 Specific Considerations
Unless specifically exempted, all pesticide labels shall contain the

following:
A. Product Information
1. Name and Ingredient Statement
This includes: a) Trade or commercial name of the

product; b) the common names of all active ingredients in
the product (approved International Standards
Organization names, or when no ISO name has been
recommended, one that has been accepted by a local
standard association); c) the chemical classification of the
pesticides; and d) the minimum guaranteed amount of
each active constituent present shall be clearly described
as follows:
a. Solids, Viscous liquids, Aerosols and Volatile

liquids: grams per kilogram (g/Kg)
b. Other liquids: grams per liter (g/L) (e.g. ‘400 g/L

2,4-D’ as sodium salt’ not ‘400 g/L sodium salt
2,4-D’).
2. Solvent Statement
Where a solvent is present, the identity and concentration

shall be stated. If the solvent significantly contributes
either to user’s hazard or flammability of the product,
appropriate standard symbols, which indicate flammability
and phrases, which indicate user’s hazard shall be
included on the label.
3. A general statement summarizing the use of the product

shall be placed as near as possible to the trade name,
(e.g., FOR CONTROL OF POST-EMERGENCE ANNUAL
BROADLEAF WEEDS IN RICE).
The statement shall draw the user’s attention to the crops

on which the pesticide is registered and can be used.
36
4. The net weight or volume (in metric units) of the product in
the container.
5. Name and address of manufacturer, distributor or agent.

(The person or company responsible for registration of the
product in the Philippines).
6. The FPA registration number and the phrase

REGISTERED WITH THE FERTILIZER AND PESTICIDE
AUTHORITY PURSUANT TO P.D. 1144 must be included
on the label.
7. Month and year of formulation. The statement “Under

proper storage, this product is best before (month and
year)” is required for products with shelf life less than two
years.
8. Identification number of manufacturing lot or batch.
B. Directions for Use
1. The directions for use on the label must clearly indicate

how, when and where the product can be legally,
effectively and safely used with maximum efficiency and
minimum risk. This information may be repeated and
expanded in separate technical or promotional literature or
label leaflets. However, even if leaflets are used, the
LABEL ON EVERY CONTAINER OR OUTER PACKAGE
MUST ALWAYS SUPPLY THE ESSENTIAL
INSTRUCTIONS NEEDED AT THE TIME OF USE.
2. Information essential to the proper use of the product in all

circumstances shall be included, such as: a) Practical
advice on preparing, mixing and applying the product, and
b) Compatibility of the product with other products.
3. Information about the recommended uses of the product

shall be clear and specific, using names, terms or
descriptions that will accurately inform the user as to the
pests controlled.
4. Directions for use must include information on:
a. Any warnings intended to prevent incorrect or misuse

of the product, example:
‘Do not use on sandy soils’

‘Apply only at the 2-5 leaf stage’
‘Do not apply when rain is imminent/coming’
37
b. Crops and pests for which the product has been
officially approved and registered.
c. Application rates and statement critical to the

effective use of the product on each crop and pest
including timing and method of application. A
tabular format is often the clearest method of
expressing these. Statements should be short,
clear and concise. Common names for pests
should be used to completely replace scientific
names; simplify labels where possible by using
phrases known to users.
d. Calibration of measuring device. Labels shall show

doses in mL. or gram. A suitable measuring device
shall be provided.
e. Pre-harvest Interval. A statement, where required,

of the period which shall elapse between last
application of the product AND: (a) harvest of plant
products; (b) grazing of treated areas;(c) slaughter
of treated animals for food; (d) feeding produce to
domestic animals; (e) saving, offering for sale or
using produce such as milk or eggs for human
consumption; (f) seeding or planting of subsequent
crops; OR the withdrawal period for treated feed to
avoid unacceptability of residues in animal
products. This is known as the ‘withholding period’
or ‘pre-harvest interval’.
f. Re-entry period.
g. Restrictions and limitations, if there are any.
Pre-harvest interval, re-entry period and restrictions

and limitations, if required, shall be placed close to
the Directions for Use and on the same panel of the
label.
Extensive directions for use may be contained in a

leaflet or pamphlet that is securely attached to the
package or enclosed within the outer packaging.
A separate leaflet in local dialect shall contain

information on pesticide threshold, protective
clothing needed, direction for use, and re-entry
period and pre-harvest interval. The telephone
number of responsible person of the company who
can give information about the product especially
for Categories I and II formulations shall be printed
in the leaflet.
38
C. Directions for Storage and Disposal
1. Directions for safe storage including physical and chemical

hazards, e.g. flammability, explosivity and others.
2. Directions for disposal of surplus pesticides and

containers, and caution on re-use of container.
3. Any special recommendation on storage conditions for the

container and product.
D. Safety Precautions
1. All information in this regard shall be stated in English,

Filipino, or any major local dialect except for small packs of
100 mL where only Filipino language must be used.
2. The appropriate signal words, symbols, pictograms, and

color bands shall appear on the label according to the
primary and secondary hazards posed by the product.
3. The color band along the base of the label shall have a
width equal to at least 11.5% and not more than 30% of
the height of the label. Signal words and symbols shall be
superimposed on the band in contrasting colors, i.e., black
for the red and yellow bands; white for the blue band. The
signal words shall be printed in easily read capital letters of
an upright non-serif character and be conspicuous in
comparison with any other matter on that panel.
4. The statement, in capital and bold letters: KEEP OUT OF

REACH OF CHILDREN shall be displayed permanently on
the front page.
5. Hazard/safety information shall be presented with simple

concise statements based on toxicity classification
including secondary hazards, and should answer the
following:
THE PRODUCT IS (type of hazard…)

WHEN WORKING WITH OR PREPARING THE
PRODUCT (explain appropriate actions)
WEAR (specify personal protective equipment needed)

IF CONTAMINATION OCCURS (appropriate steps)
AFTER USE (proper procedures)
39
It is often helpful to capitalize the first few words of such
direction as shown above to draw attention to the specific
step of possible concern to the user.
6. Sample statements are contained in Section 2.9.
E. First Aid, Information for Physicians and Treatment
1. Signs and symptoms of poisoning of the particular

pesticide.
2. First aid measures for the particular pesticide.
3. Information for Physician (Toxicity Categories I & II),

including antidotes and treatment.
4. Sample statements Section 2.9.
F. Prohibition/Warranty Statements
1. The following statement is required:
“It is a violation of FPA rules and regulations to use

this product in a manner inconsistent with its label.” If
the above statement is not printed on the label, license
shall be cancelled.
2. The following statement shall be allowed:
“No warranty of any kind, expressed or implied, is

made concerning the use of this product. User
assumes all risks and liabilities resulting from
handling, use or application.”
2.8.5 Classification on the Basis of Toxicity and Hazard
Consistent warnings in the label based on toxicity and other

hazards coupled with training, is generally accepted as a way to protect
users and others involved in the application of pesticides from accidents
and misuse.
Color Bands, Signal Words, Symbols and Pictograms based

on Toxicity and Hazard. Table 3 shows the appropriate bands of color
to be placed on pesticide labels. Superimposed on this band are the
appropriate signal words and symbols to signify acute toxicity and degree
of hazard to the users and pictograms indicating safety in handling.
Inhalation toxicity shall also be considered for volatile materials

such as fumigants. Where data on inhalation toxicity are required
because of volatility, use pattern and opportunity for significant exposure
shall be considered.
40
2.8.6 Criteria for Classification
1. Where it is shown for a particular compound that the rat is not the
most suitable test animal (for example, if another species is
conspicuously more sensitive or more closely resembles man in
its reactions) then the classification of that compound shall take
this into account.
2. In practice, the majority of classification shall be made on the

acute oral LD50 value. However, dermal toxicity shall always be
considered since it has been found that, under most conditions of
handling pesticides, a high proportion of the total exposure is
dermal. Classification based on dermal data in a class indicating
a great risk is necessary when the dermal LD50 values indicate
greater hazard than oral LD50 values.
3. If the active ingredient produces irreversible damage to vital

organs, is highly volatile, is markedly cumulative in its effect, or is
found after direct observation to be particularly hazardous or
significantly allergenic to man, then adjustments to the
classification can be made by classifying the compound in a class
indicating a higher hazard. Alternatively, if it can be shown that
the preparation is less toxic or hazardous than expected from
consideration of the LD50 values of the ingredient or ingredients, or
for any other reason, adjustments should be made in classifying
the compound in a class indicating a lower hazard.
4. In certain special cases, the acute oral or dermal LD50 values of

the compound or formulation shall not be used as the main basis
for classification. Provision is made for the classification of a
particular compound to be adjusted if, for any reason, the acute
hazard to man differs from that indicated by LD50 assessments
alone. In such cases (for example, aerosol preparations, other
special formulations and fumigants), more appropriate criteria
shall be used (e.g. inhalation, toxicity for volatile compounds).
5. If the formulation contains more than one active ingredient of

significant toxicity-enhancing properties, then the classification
shall correspond to the toxicity of the mixed ingredients.
2.9 SAMPLE STATEMENTS: WARNING AND PRECAUTIONS, SYMPTOMS,

FIRST AID AND TREATMENT, AND INFORMATION FOR PHYSICIANS
2.9.1 Warning Statements
The following are generally appropriate warning statements for

pesticide formulations falling under FPA Toxicity Categories I and II.
However, they may require modification in some cases. For example,
41
reference to inhalation would not be appropriate for granular formulations
or baits containing rodenticide.
A. Category I
“DANGER: This product is highly toxic and may cause death

if swallowed, inhaled or absorbed through the skin.” Follow
directions for use carefully.
B. Category II
“WARNING: This product may be harmful if swallowed,

inhaled or absorbed through the skin.” Follow directions for
use carefully.
C. Categories III & IV
“Dangerous if not properly used”. No warning statement is

necessary unless the substance is a recognized cause of
dermatitis or allergy.
2.9.2 Precautionary Statements
Sufficient information shall be included under the heading

“PRECAUTIONS” to advise the pesticide user on the following aspects:
(a) Storage; (b) Avoidance of absorption during mixing and use, (c)
Washing after use; (d) Container disposal; (e) Avoidance of
contamination of water supplies; and (f) Wearing of protective clothing.
The preferred order of precautionary statements is as above.
The following statements are generally applicable to pesticide

formulations in the various categories. However, there will be instances
when modified or additional statements will be appropriate. If
appropriate, precautions against flammability or explosion shall also be
included.
A. Category II
“Store in original container, tightly closed, away from food and

feeds.”
“Do not eat, drink or smoke while using.”
“Wear protective clothing including waterproof gloves and overalls
or an old long sleeve shirt, particularly when handling the
concentrate.”
or
“When dusting wear protective clothing including gloves, a

respirator and overalls or an old jacket.”
42
or
“When handling granules, wear protective clothing including

gloves.”
“Do not spray against the wind.”
“Avoid skin contamination and inhalation of spray mist or dust.”
“Wash splashes of concentrate off skin immediately (liquid
concentrate only).”
“Place baits out of reach of children and domestic animals.”
“Wash hands and exposed skin before eating and after work.”
“Wash separately contaminated clothing and protective equipment
after each use.”
“Burn or bury empty container.”
“Avoid contamination of any water supply with chemical or empty
container.”
“Remove unused baits and burn any dead pests.” (Rodenticides)
B. Category III
“Store in original container, tightly closed, away from feeds and

foodstuffs.”
“While mixing or applying, wear protective clothing, particularly
gloves.”
“Avoid skin contact and inhalation of spray mist or dust.”
“Wash hands and exposed skin before eating and after work.”
“Dispose off empty container safely.”
container.”
“Remove unused baits and burn any dead pests.” (Rodenticide)
“Flammable. Contents under pressure. Store in a cool area. Do
not spray near sparks or on an open flame. Do not spray
directly onto animals or fish tanks. Remove or cover all
exposed food. If spraying is heavy, do not enter room for
30 minutes. Do not puncture or burn container, even when
empty.” (Aerosols)
C. Category IV
“Store in original container, tightly closed.”

“Avoid skin contact and inhalation of spray mist or dust.”
container.”
“Remove unused baits and burn any dead pests.” (Rodenticides)
“Flammable. Contents under pressure. Store in cool area. Do
not spray near sparks or open flame. Do not apply directly
to animals or fish tanks. Remove or cover all exposed
food before spraying. If spraying is heavy, do not enter
room for 30 minutes. Do not puncture or burn container,
even when empty.” (Aerosols)
43
2.9.3 Mandatory Statements based upon Secondary Hazard
Mandatory precautionary statements relating to skin and eye

irritation must be prominently displayed on the label.
Inclusion in the label of other effects noted in the testing may be

required along with the secondary hazard warnings. The principal
consideration in writing these statements is to clearly convey the type of
hazard and then state or suggest how it may be avoided.
A. Skin Irritation
Test Result Precautionary Statement
Corrosive Corrosive: - Avoid contact with skin

and eyes.
Severe Irritation, Severe skin irritant

72 hours
Moderate Irritation, Skin irritant

72 hours
Mild or No Irritation, None

72 hours
B. Eye Irritation
Effects not reversed Can cause severe eye damage

after 21 days; or if pH<3 or blindness. Avoid contact with
or >11.5 or severe skin eyes.
irritant
Effect reversible, May cause severe temporary

21 days eye irritation.
Avoid contact.
Effect reversible, May cause eye irritation.

7 days Avoid contact.
Clear, 24 hours None
2.9.4 Signs, Symptoms and Treatment of Poisoning
These are only necessary for FPA Toxicity Categories I and II.
They shall be expressed in terms readily comprehensible to the layman
so that a user may recognize signs or symptoms of poisoning by himself.
44
Often, it is necessary to make deductions of the likely signs of
poisoning from the acute toxicity experiments on laboratory animals, in
which case, the predicted signs shall be preceded by a statement to the
effect “Signs of poisoning may include…”
In some cases, pesticides belong to well-documented categories

such as the organophosphates or the carbamates. To assist those
preparing labels of such pesticides, the following list of signs and
symptoms may be used, as appropriate:
A. Organophosphate or Carbamate
Signs and symptoms of acute poisoning include excessive

sweating, tearing of eyes, salivation, headache, giddiness, blurred
vision, nausea, vomiting, abdominal cramps, diarrhea, chest
tightness and discomfort, and constricted pupils. In severe
poisoning, muscle twitching and inability to walk, coma and
respiratory arrest may occur.
B. Organochlorine
Signs and symptoms of acute poisoning include apprehension,

excitability, dizziness, headache, nausea, vomiting, trembling,
incoordination and convulsions.
C. Nitrophenolic and Nitrocresolic Herbicide
Signs and symptoms of acute, early poisoning include profuse

sweating, headache, thirst, malarse and lassitude. Serious
poisoning are manifested by warm, flushed skin, rapid heart rate,
palpitations, fever, restlessness and convulsions.
D. Warfarin or Coumarin Type Compounds
Signs and symptoms of poisoning include bleeding from nose,

gums, gastrointestinal tract, easy bruising and anemia.
2.9.5 First Aid Statements
These shall consist of simple measures that may be carried out by

a layman without the need for special equipment. As appropriate, they
shall cover poisoning by the oral, dermal and inhalation routes of
poisoning, although generally for most pesticides (except for fumigants)
only the first two (2) routes are relevant. Contamination of the eyes may
also be covered.
45
An appropriate selection of the following should be made:
A. For Ingested Pesticide
1. If no organic solvent
“If swallowed and patient is conscious, give 1 glass of

water and induce vomiting by tickling back of throat or
pressing back of tongue with a finger or blunt instrument.
Repeat procedure until vomit fluid is clear in appearance.
Get medical attention immediately.”
2. If with kerosene, xylene or other organic solvents
“If swallowed and patient is conscious, give 1-2 glasses of

water. Do not induce vomiting. May do careful gastric
lavage if feasible. Get medical attention immediately.”
B. Inhaled
“If inhaled, remove from contaminated area and bring patient to

fresh air. If breathing stopped, apply artificial respiration. Get
medical attention as soon as possible.”
C. Skin Contact
“In case of skin contact, remove contaminated clothing and wash

affected areas with soap and plain water. Get medical attention
as soon as possible if symptoms of poisoning are occurring.”
D. Eye Contamination
“In case of splashes in the eyes, flush eyes with clean running
water for at least 15 minutes and get medical attention
immediately.”
2.9.6 Special Note on Emulsifiable Concentrates and Other Formulations

with Hydrocarbon Solvents
Problems may occur if emulsifiable concentrates are vomited and

if, during vomiting, some of the vomit fluid containing the solvent is
accidentally inhaled into the lungs. Because of their low surface tension,
hydrocarbon solvents may spread all over the respiratory surface of the
lung, causing a chemical pneumonitis that may be fatal.
The risk of inhaling the solvent must be balanced against the risk
of systemic poisoning if the pesticide is allowed to remain in the gastro-
intestinal tract.
46
For substances in Category I, it is suggested that the risk of
systemic poisoning might be greater than that of chemical pneumonitis,
and the recommendation to cause immediate vomiting may apply. A
physician shall be consulted immediately.
For substances in Category II, vomiting should not be induced

unless there is a delay (one hour is requested) in obtaining medical
treatment.
For emulsifiable concentrates in Categories III and IV, the

paramount consideration may be the systemic toxicity of the solvent,
which may be greater than that of the pesticide itself. In this regard,
aromatic solvents are appreciably more toxic than aliphatic solvents.
Therefore, it is recommended that labels of Categories III and IV
formulations with aromatic solvents contain the statement “not to induce
vomiting or to do so only if there is a delay in obtaining medical
treatment.” Labels of Categories III and IV formulations containing
aliphatic solvents should contain a recommendation not to cause vomiting
at all.
2.9.7 Information for Physicians
This will vary from substance to substance. However, the

following phrases may be useful:
A. Carbamates
Contains a cholinesterase inhibitor. If swallowed, do

careful gastric lavage. Treat with atropine sulfate as antidote.
Maintain patent airway and fluid and electrolyte balance. Never
give opiates, phenothiazines, xanthines (aminophylline,
theophylline, caffeine, etc.) and other respiratory depressants.
B. Organophosphates
Contains a long-acting cholinesterase inhibitor. If

swallowed, do careful gastric lavage with activated charcoal and
follow with sodium sulfate cathartic. Treat with cholinesterase
reactivator (pralidoxime or obidoxime, intravenous) if within 24
hours of poisoning. Give atropine sulfate as main antidote.
Maintain patent airway, vital signs and fluid and electrolyte
balance. Never give opiates, phenothiazines, antipyretics,
xanthines (aminophylline, theophylline, caffeine) and other
respiratory depressants.
47
C. Organochlorines
Treatment is supportive and symptomatic. Remove poison

from body. Maintain patent airway and tissue oxygenation.
Control convulsions with pareneral diazepam or short-acting
barbiturate. Do not give epinephrine or other adrenergic amines.
Oral cholestyramine can promote excretion of swallowed
chemical. Phenytoin can control convulsion and hasten
metabolism of organochlorines.
D. Dithiocarbamates (Metallo-dithiocarbamates)
Can cause irritation to skin and mucous membranes. In

cases of systemic poisoning, avoid fats and oils. Alcohol should
be avoided since this will result in “disulfiram-like” reaction. Give
supportive and symptomatic therapy.
Ethylene bis-dithiocarbamates can cause irritation of skin

and mucous membranes. In systemic poisoning, the chemical is
converted to a goitrogen. Give supportive and symptomatic
therapy.
E. Nitrophenolic and Nitrocresolic Herbicides
This is a potent stimulant of cellular metabolism.

Treatment is supportive and symptomatic. Never give atropine
and antipyretics. Agranulocytosis can occur in large dose
poisoning.
F. Chlorophenoxy Compounds
Moderately irritating to skin and mucous membranes. In

case of systemic poisoning, promote alkaline diuresis with
intravenous bicarbonate. Never give atropine, aspirin or other
antipyretics to control fever.
G. Pyrethroids
Can cause irritation and sensitization on exposure of skin

and mucous membranes. In case of systemic poisoning, treat
symptomatically with Diazepam for convulsion, maintenance of
fluid and electrolyte balance. In oral poisoning, avoid fats, oils and
milk. Adrenaline and hydrocortisone may be indicated in
anaphylactic reactions.
H. Bipyridyls (Paraquat and Diquat)
Can be fatal if swallowed. Contact with the liquid may

cause severe damage to eyes or skin. If swallowed, give
immediately Fuller’s Earth (Bentonite) or Activated charcoal or
48
Kaolin Suspension. Lavage well and administer cathartic. Please
refer to MSDS or booklet on paraquat poisoning. If necessary,
admit into intensive care unit for proper management of hepatic,
renal and pulmonary complication.
2.9.8 Position of Information on the Label
The following Table 4 and diagrams show the recommended

position of information on labels. While flexibility shall be permitted to
accommodate the needs of different products, consistent position of
information on all labels makes it easier for the user to find the needed
information quickly and easily.
2.9.9 Sample Pesticide Labels
Samples of labels are presented in Annex IV to provide a guide to

grouping and position of the various types of information. Consistent
position of information on the label shall enable a user to locate quickly
the needed information and add to the usefulness of the label. Labelling
of over-the-counter household pesticide shall follow sample labels as
specified in Annex V while those for institutional products shall comply
with the guidelines in Section 2.8.
2.10 REFERENCES TO ACCEPTABLE PROTOCOL
Bioefficacy Test Protocols, FPA Revised Guidelines, 1985.
FAO Guidelines for the Submission and Evaluation of Pesticide Residue Data for
the Estimation of Maximum Residue Levels in Food and Feed. FAO,
Rome, 1997.
FAO Guidelines:
Crop Residue Data
Packaging and Storage of Pesticides
Good Labelling Practice for Pesticides
Disposal of Waste Pesticides and Containers on the Farm
Environmental Criteria for the Registration of Pesticides.
FAO Harmonized Test Protocols, 1994.
Good Analytical Practices, Report of the Fifteenth Session of the Codex

Committee on Pesticide Residues, The Hague, 3-10 October 1983.
(attached as Annex VI)
Good Laboratory Practice, C (81) 30. Organization for Economic Cooperation

and Development, Paris.
49
Guidelines on Pesticide Residue Trials to Provide Data for Registration of
Pesticides and the Establishment of Maximum Residue Limits. FAO of
the United Nations; Rome, 1986.
Guidelines for Testing of Chemicals, Organization for Economic Cooperation and

Development, Paris, 1981.
Guidelines for Registering Pesticides in the U.S., Environmental Protection

Agency
Internationally Accepted Guidelines
Principles for the Toxicological Assessment of Pesticide Residues in Food,

Environmental Health Criteria, No. 104. 1990, 117 pages ISBN
9241571047.
Pesticide Residues in Food. FAO-WHO Joint Meeting on Pesticide Residues in

Foods Part I: Pesticide Residues Evaluation, Part II: Toxicology
Evaluation.
The Use of FAO Specifications for Plant Protection Products, FAO Plant
Production and Protection Paper 13, Rome, 1979.
WHO Specifications for Pesticides Used in Public Health, Sixth Ed., Geneva,
Rome, 1985.
Codex Recommended National Regulatory Practices to Facilitate Acceptance

and Use of Codex Maximum Limits for Pesticide Residues in Foods,
ALINORM 85/24A - Add. 2, FAO, 1985.
50
Table 1. SCHEDULE OF REVISED FEES AND CHARGES FOR PESTICIDE
PRODUCT REGISTRATION*
ITEM Fees and Charges

(in Pesos)
A. New Applications – Filing Fee
Active Ingredient 4,500.00

Product 3,000.00
B. Conditional Registration/Renewal (Annually)
Product
Category I and II 5,000.00
III and IV 3,000.00
Active Ingredient
III and IV 5,000.00
C. Full Registration/Renewal (3 years validity)
Product
III and IV 7,000.00
Active Ingredient
III and IV 15,000.00
D. Submission of Additional Data/Resubmission 4,000.00
E. EUP Application/crop/season
I – A and B 1,500.00
II and III 3,000.00
F. Label Expansion/Crop 3,000.00
Pursuant to Administrative Order No. 13, Series of 2000.
*
Subject to change
51
Table 2. DATA REQUIREMENT FOR THE REGISTRATION AND EXPERIMENTAL USES OF PESTICIDE PRODUCTS
2
NAME OF DATA REQUIREMENT USE PATTERN ACTIVE FORMULATION EUP2 REMARKS
INGREDIENT
1 2
AGR HSLD Tech Grade
1.0 GENERAL
1.1 Name/address of applicant R R R R A Required in all cases

1.2 Product Trade/Brand Name R R R R 2, 3 ditto
1.3 Manufacturer of Technical Pesticide R R R R A ditto
3
1.4 Description of Production Process R R R R X ditto
2.0 SPECIFICATIONS
2.1 Common Name of Active Ingredient R R R R 2, 3 Required in all cases
52
(Proposed or Accepted ISO name)
2.2 Chemical Name of Active Ingredient (IUPAC R R R R 2, 3 ditto
designation)
2.3 Chemical Abstract Service Number R R R X 2, 3 ditto
2.4 Formula (empirical and structural) R R R X 2, 3 ditto
2.5 Composition of Technical including R R R X 2 ditto
impurities (all materials present at or over
4
0.1%)
2.6 List of ingredients and percent variations of R R R R 2, 3 ditto
5
each
2.7 Appearance, color, state, odor R R R R A ditto
2.8 Melting point R R R X A If solid at room temp
2.9 Boiling point R R R X A If liquid at room temp
-3
2.10 Vapor pressure R R at 20-25°C X A Only if >10 Pascal
2.11 Density or Specific Gravity R R R R A Required in all cases
2.12 Octanol Partition Coefficient R X R X A Required if Technical A.I. is
- half-life in soil organic and non-polar
- Koc, organic carbon partition coefficient
Table 2. continued
2
INGREDIENT
1 2
AGR HSLD Tech Grade
6
2.13 Formulation Type (GCFP code) R X X R 2, 3
2.14 Storage stability R R X R 2, 3
2.15 Solubility in water and solvents R R R X 2
2.16 Suspensibility/Emulsifying Characteristics R X X R 2
2.17 Known capability/incompatibility with other R X X R X
pesticide products or Active Ingredients
2.18 Flash point and other indicators of @ @ R R 2, 3 If product contains
flammability combustible liquid
2.19 pH R R R R 2, 3
53
2.20 Methods of destruction or disposal R R R R A For EUP, include treated crop
disposition
2.21 Packaging type, sizes and materials R R R R A
2.22 Assessment of Need of Child Resistant X R X R X For Toxicity Category
Packaging I and II
2.23 Analytical methods for constituents R R R R 2
2.24 Submittal of product samples R R 10 g 500 mL / 0.5 Kg X Analytical grade A.I., 1 g
required unless reasons
provided by applicant
3.0 BIOEFFICACY
(Typical Formulation)
3.1 Description of mode of action or effect on R X X R X

pest for which control is claimed
3.2 Pests controlled and names of crops, R R X R A
materials or premises to be protected
3.3 Application rate (Kg a.i./Ha or % a.i. spray R R X R A
dilution for each site/pest listed
Table 2. continued
2
INGREDIENT
1 2
AGR HSLD Tech Grade
3.4 Frequency and timing of application for each R R X R A

site/pest listed
3.5 Method of application (ULV, backpack R R X R A
sprayer, fumigation, etc.)
3.6 Phytotoxicity R X X R 2, 3
3.7 Results of laboratory studies, if any R R X R A
3.8 Complete description and data from local R R X R X
field trials or relevant test performed abroad
or request for waiver for each site/pest on
label
3.9 Effects on beneficial organisms @ X R Appropriate X Technical or formulated
pest/predator or material may be used; reflect
54
parasite field use conditions.
complex
4.0 TOXICOLOGY
7
4.1 Estimation of Acute Oral LD50 R R Study in rat Study in rat A Calculation permissible in
some cases from TGAI
7
4.2 Estimation of Acute Dermal LD50 R R Study in rabbit Study in rabbit A ditto
4.3 Inhalation LC50 @ @ Study in rat Study in rat A Required only if pesticide has
high vapor pressure or if used
as gas, fog, smoke, fumigant
or contains respirable dust
4.4 Skin Irritation/Corrosivity R R Unabraded Unabraded A

rabbit skin rabbit skin
Table 2. continued
2
INGREDIENT
1 2
AGR HSLD Tech Grade
4.5 Eye Irritation @ @ X Study in rabbit 2, 3 Not required if pH less than 3

or greater than 11.5; or if
corrosive to skin
4.5.1 Dermal Sensitization R R X Study in guinea 2, 3
pig
4.6 Allergic Sensitization @ @ X R 2 If positive in 4.5.1
4.7 Subchronic toxicity (21 days, dermal) X @ Study in rodent X 2, 3 Required for household
products if significant dermal
exposure is expected from use
55
4.7.1 Subchronic toxicity (90 days, oral) R @ Studies in X 2 Two species for food crop,
rodent (oral) one for non-food; required for
household if significant
exposure
4.7.2 Subchronic toxicity (90 days, dermal) @ @ Study in rodent X 2 Rarely required. Special
(dermal) exposure cases.
4.8 Teratology R R Studies in rabbit X 2, 3
and rat
4.9 Reproduction R @ Study in rabbit X 2, 3 Two generations adequate
or rat (preferred)
4.10 Chronic toxicity R @ Lifetime in rat X X Not required for EUP but
submit if available
4.11 Oncogenicity R @ Lifetime in rat X X ditto
and mouse May be combined with chronic
toxicity test
4.12 Mutagenicity R R Multi-test X 2, 3 Battery should include point
battery mutation, chromosomal
aberration and in vivo
mammalian tests.
Table 2. continued
2
INGREDIENT
1 2
AGR HSLD Tech Grade
4.13 Acute delayed neurotoxicity @ @ Study in hen X 2, 3 When cholinesterase

depression expected
4.13.1 Subchronic neurotoxicity @ @ Hens or X 2, 3 If effects noted in 4.13 or
mammals mammalian acute studies
4.14 Pharmacokinetics (absorption, storage, R @ Appropriate X 2, 3 For EUP only if crop is to be
metabolism and elimination) spec. used.
4.15 Observations on Man, if any R R R R A
5.0 HUMAN EXPOSURE AND SAFETY
5.1 Assessment of applicator exposure @ @ X Monitoring or 2, 3 Required when potential

calculation exposure is close to an effect
56
level
5.2 Assessment of farm worker exposure @ X X Monitoring or 2, 3 Required for Toxicity Category
calculation 1 when hand labor in dense
foliage is concern; and toxic
compounds
5.3 Signs and symptoms of acute human R R Observations Observations or A
poisoning or judgments judgments
5.4 Recommended first aid procedures R R R R A
5.5 Recommended medical treatment for R R R R A
poisoning, include antidote if any
5.6 Proposed Acceptable Daily Intake R X Calculated X 2, 3 Food uses only; For EUP if
not crop destruct basis.
5.7 Protective equipment @ @ R R A If needed; Required for
Toxicity Category I and II.
5.8 Other precautions @ @ R R A If needed.
Table 2. continued
2
INGREDIENT
1 2
AGR HSLD Tech Grade
6.0 ENVIRONMENTAL EFFECTS
6.1 Avian acute oral toxicity R X X Test in one species 2, 3 Suitable species, pigeon, quail, pheasant,
for each typical duck or a Bengalese finch; hen not suitable
formulation
6.2 Avian dietary acute toxicity @ X X Test in one species as X If indicated by Acute test results and type of
needed to assess formulation and use
potential effects
6.3 Fish acute toxicity R X 96 hour test in two X 2, 3 Suitable species include rainbow trout,
species one of which is zebra fish, fat head minnow, tilapia
a local species fingerlings
57
6.4 Subacute fish toxicity @ X Prolonged X X Where prolonged exposure likely; Test
exposure test, one period up to 30 days
or more species
6.5 Aquatic acute toxicity R X 48 hour acute test X X Suitable fish food species, e.g. Daphnia
suitable species
6.6 Accumulation in fish @ X Test in one species X X Where indicated by use pattern, formulation
type and partition coefficient
6.7 Avian reproduction @ X Test in one species X X If need is indicated by feeding study results
6.8 Fish reproduction @ X Test in Daphnia X X Test to be performed if persistent exposure
and one fish indicated by use pattern and chemical
species persistence
6.9 Acute toxicity to honey bees @ X R X X Test to be performed if use involves crop
where bees are present during or just after
treatment
6.10 Contact toxicity to honey bees @ X X Typical formulation X Test needed for uses involving exposure
and acute test shows high bee toxicity
6.11 Soil non-target microorganisms @ X X Typical formulation X Required if high soil concentrations
expected from use; Test maybe conducted
with TGAI or formulation
6.12 Soil non-target macroorganisms @ X X Earthworms X Same as above; also collect residue data if
high avian toxicity
Note: Special pen and field studies may be required depending upon uses, formulation and results of above studies
Table 2. continued
2
INGREDIENT
1 2
AGR HSLD Tech Grade
7.0 RESIDUE IN FOODS

For food use only
7.1 Identity of principal residues, metabolites R X Each crop X 2, 3 Food/feed uses only
and degradation products in edible crops,
foods or feeds
7.2 Residue decay curves for residues on crops R X Each crop X 2, 3 Food/feed uses only
to be treated
7.3 Residues of active ingredient and principal R X Each crop X 2, 3 Feed or pasture/range – land
metabolite in animals fed treated feeds or use only
grazed on treated fields or pastures
7.4 Effects of food processing or home @ X Each crop X 2, 3 For foods which are processed
58
preparation on residues or cooked before eating
7.5 Analytical method for detection of principal @ X Each crop X 2, 3 Food/feed uses only when
residues, metabolites on treated finite residue expected
commodities
7.6 Proposed maximum residue level for each R X Each crop X 2, 3 Food/feed uses only
crops, food, feed or animal expected to Residue definition also
contain residues required for enforcement
Note: Residue data may also be required for inerts which are not provided a general exception or generally regarded as safe.
Above residue data not required for EUP on a crop – destruct basis.
Table 2. continued
2
INGREDIENT
1 2
AGR HSLD Tech Grade
8.0 ENVIRONMENTAL FATE AND

TRANSPORT
8.1 Volatility R R R X X
8.2 Adsorption/desorption @ X Test in two soil X X If pesticide likely to reach soil
types or water; radio-labelled test
material best.
8.3 Leaching R X Test in several Sometimes X Field leaching tests may also
soil types be required.
59
8.4 Degradation in soil @ X Test in Sometimes A Required for pesticides
agricultural soil; reaching the soil. Simulate
sandy loam field conditions. Field study
may be required.
8.5 Biodegradation @ X Approximate X X If applied directly to water or
field conditions likely to enter due to
formulation or use. Field tests
may be required.
8.6 Hydrolysis @ X R X A Same as above.
8.7 Aqueous photolysis @ X R X A Same as above.
8.8 Analytical method – residues in soil R X R X X
8.9 Analytical method – residues in water @ X R X X When used directly or
expected to reach water.
9.0 LABELLING
9.1 Proposed toxicity category R R R R A

9.2 Draft label (3 copies) R R X R A See note for EUP’s. A.I. must
meet shipping label requirements.
Note: EUP labels may be typewritten and need to contain product identification warnings and precautions for storage, use and disposal, symptoms
and signs of poisoning, first aid procedures and medical treatment, application directions and a “Experimental Not for Sale” statement and
the name and address of the manufacturer.
Notes to Data Requirement Table:
1 Symbols used in the table:

R Test required
@ Conditionally required; see remarks for conditions
X Not required
2 These columns indicate whether the data are required to support the registration
or EUP for the Technical Active Ingredient, the Formulated Product or one or
more types of EUP. An “X” indicates no requirement.
Additionally for EUP’s “A” indicates the data are required for all types, or else the
type number (1, 2, 3) appears. In no case will a study be required for an EUP if
not necessary for ultimate registration.
The symbols do not designate the form of the compound to be used for the test.
It may either be the active ingredient, the formulated product or a typical
formulation. Most toxicological studies for example are conducted with the
technical active ingredient while bioefficacy studies are performed with specific
product or representative formulation. Environmental fate and fish and wildlife
studies usually require either the technical active ingredient or a representative
formulation as the test material. An indication of test material is made in many
cases where it would not be obvious, but specific test protocols such as those
contained or referenced in the FAO guidelines, in OECD protocols or US EPA
testing guidelines should be consulted or the applicant should consult FPA prior
to conducting the test.
Where test species are noted, these are the species most generally
recommended by international and national guidelines; other species may be
acceptable or even preferable in certain circumstances. Any question on species
must be resolved by the FPA.
3 For Technical Materials, a description of the manufacturing process is required

including an analysis of steps which may cause formation of toxic contaminants.
For formulations, describe the process and how the various materials are
combined to formulate the end-product from the technical.
4 All ingredients, contaminants, unreacted starting materials must be noted and

identified and the nominal concentration of each is reported if it constitutes 0.1%
or more of the product. For purposes of this requirement, some isomers may be
identified and quantified as a group. Also, the FPA may ask for qualification of
materials below 0.1% on a case-by-case basis if there is a special concern with
its toxicity. Generally, these data are confidential.
5 The statement of ingredient for each product is the specification by which it will
be judged. Upper and lower limits for each ingredient must be specified
consistent with the expected variation in the production process. Efficacy
determination by FPA may be made with lower limits on A.I. and risk
assessments with upper limits. These data are generally considered confidential
except for information required on the label although it may be released for safety
60
consideration. The difference between this and the previous requirement is that
this is designed to spell out the positive aspect of product formula. This focuses
on the intentionally added ingredients and the potential variations in the
percentages. It also bears on the variation in the impurities all as a function of
manufacturing quality control. This specification is used in comparison with
international specifications. The previous requirement focuses mainly on
identification of the impurities for the purpose of assessing risk.
6 Global Crop Protection Federation (GCPF) Formulation Codes: These are

examples of the type of code used. The entire list is published in “Catalog of
Pesticide Formulation Types Coding System”, Technical Monograph No. 2,
GCPF, Avenue Hamoir, 121180 Brussels, Belgium. The entire set should be
reproduced in the guidelines if this convention is adopted.
EC – Emulsifiable Concentrate SC – Suspensible Concentrate

EO – Emulsion, water in oil WP – Wettable Powder
EW – Emulsion, oil in water GR – Granule
7 An estimate of the LD50 sufficient for labelling purpose can be obtained using
significantly fewer animals than the classical LD50 studies and will be sufficient in
most cases. Occasionally, a more complete study may be needed with the
active ingredient to study the mode of chemical toxicity.
61
Table 3. CLASSIFICATION OF PESTICIDES BASED ON TOXICITY AND
HAZARD 1
Acute Toxicity to Rat3

Category and Signal Color Band Oral LD50 Dermal LD50
Words Symbol 2 (mg/Kg BW) (mg/Kg BW)
3
Solid Liquid Solid Liquid
CATEGORY I 50 200 100 400

RED or or or or
DANGER: POISON less less less less
CATEGORY II 51 201 101 401

YELLOW to to to to
WARNING: HARMFUL 500 2000 1000 4000
CATEGORY III 501 2001 Over Over

BLUE to to 1000 4000
CAUTION 2000 3000
CATEGORY IV Over Over

GREEN N/A N/A
----------- 2000 3000
1
Toxicity classification based on formulation.
The FPA Classification Table is adopted from the World Health Organization (WHO)
Classification By Hazards, the only modification being in the Title and combination of
Categories 1a and 1b of the WHO Table into Category I for FPA.
2
The following shades must be used as norms: Pantone red 199-C, Pantone yellow-C, Pantone
blue 293-C and Pantone green 347-C.
3
The terms “solid” and “liquid” refer to the physical state of the product or formulation being
classified.
62
Table 4. RECOMMENDED POSITIONS AND TYPE SIZE OF INFORMATION ON
THE LABEL
Key Subject Position on Label Type Size Recommendation
A = Main Label L = Large

B = Ancillary Panels M = Medium
C = Label Leaflet S = Small (minimum)
D = Pre-measured Pack X = Emphasize by using
* = If applicable to either capitals, bold or
packaging heavy type for heading or
part/whole or phrase
Hazard Symbols A, *C and *D LX
Product Name A, *C and *D LX
Active Ingredient Statement A and *D M
Solvent Statement (if required) A and *D L
Summary of Uses A and *C LX
Net Weight A and *D M
Name and Address A and *D M or S
Directions for Use B and *C M
Withholding Period B and *C MX or SX
General Instructions for Use B and *C M or S
Warning Phrases and B and *C M

Statements
Safety Precautions B and *C MX
First-Aid Instructions and B and *C MX

Advice to Doctors
Prohibition and Warranty B and *D S

Statement
Note: Where a one-panel label is used, all the above information must be included.
Source: FAO Labelling Guidelines.
63
Chapter 3
POLICY GUIDELINES ON BIORATIONAL

PESTICIDES
64
3.1 DEFINITION AND SCOPE
3.1.1 Definition of Biorational Pesticides
Biorational pesticides are a distinct group, inherently different from

conventional pesticides. They are comprised of two major categories: the
biochemical pest control agents (e.g. pheromones, hormones, natural
plant growth regulators and enzymes) and the microbial pest control
agents (e.g. microorganisms). The relationships among conventional
pesticides, biological control agents, and biorational pesticides are
illustrated in Figure 2. Pesticides to be included in these categories must
be naturally occurring, or if man synthesizes the chemical, then it must be
structurally identical to a naturally occurring chemical. Minor differences
between the stereochemical isomer ratios (found in the naturally
occurring compound compared to the synthetic compound) will normally
not rule out a chemical being classified as a biorational unless an isomer
is found to have significantly different toxicological properties from those
of another isomer.
3.1.2 Biochemical Pest Control Agents
Biochemical pest control agents include four (4) general

biologically functional classes, which are described below:
A. Semiochemicals
These are chemicals emitted by plants or animals that

modify the behaviour of receptor organisms of like or different
kinds. They include pheromones, allomones, and kairomones.
Pheromones are substances emitted by a member of one species
that modify the behaviour of others within the same species.
Allomones are chemicals emitted by one species that modify the
behaviour of a different species to the benefit of the emitting
species. Kairomones are chemicals emitted by one species that
modify the behaviour of a different species to the benefit of the
receptor species.
B. Hormones
These are biochemical agents synthesized in one part of

an organism and translocated to another where they have
controlling, behavioral, or regulating effect.
C. Natural Plant Regulators
These are chemicals produced by plants that have toxic,

inhibitory, stimulatory, or other modifying effects on the same or
other species of plants. Some of these are termed “plant
hormones” or “phytohormones.”
65
Figure 2. RELATIONSHIPS AMONG CONVENTIONAL PESTICIDES,
BIOLOGICAL CONTROL AGENTS AND BIORATIONAL PESTICIDES
Pest Control Agents
Conventional Chemical Biological and Biologically

Pesticides Derived Pest Control Agents
Biorational All Other Living Pest

Pesticides Control Agents
- Insect Predators
- Macroscopic Parasites
- Nematodes
- Plants
Biochemical Pest Microbial Pest

Semiochemicals
Control Agents Control Agents
- Hormones - Bacteria
- Natural Plant - Fungi
Regulators - Protozoa
- Enzymes - Viruses
66
D. Enzymes
In this regard, enzymes are protein molecules, which are

the instrument for expression for gene action and that, catalyze
biochemical reactions.
3.1.3 Microbial Pest Control Agents
These biorational pesticides include (but are not limited to)

bacteria, fungi, viruses, and protozoans. The guidelines apply to all
microbial pest control agents used as pesticides, including not only those
that are naturally occurring, but also the improved strains.
3.1.4 Pest Control Organisms
Pest control organisms such as insect predators, nematodes, and

macroscopic parasites are not considered biorational pesticides, and are
exempt from the requirements of these guidelines.
3.2 REGULATION OF BIORATIONAL PESTICIDES
3.2.1 Policy Statement
This section describes the philosophy and approach to the

regulation of biorational pesticides. In adherence to the rules and
regulations of the National Committee on Biosafety of the Philippines
(NCBP), FPA shall require registrants to obtain clearance from the said
Committee prior to the registration of the product.
In regulating biorational pesticides, FPA shall recognize that these

kinds of pesticides are inherently different from conventional pesticides,
and will take due consideration that many classes of biorational control
agents pose lower potential risks than conventional pesticides. This does
not mean however, that biorational pesticide registrants shall be relieved
of the burden of proof of the safety of their products.
The most important inherent difference between biorational

pesticides and conventional pesticides are: target species specificity,
generally non-toxic mode of action, and natural occurrence of the
biorational agents. These factors provide the basis for the FPA’s
expectation that many classes of biorational pest control agents pose a
lower potential hazard than conventional pesticides and support the
approach to testing discussed in the following paragraphs.
Nevertheless, the data requirements for registration of those living

organisms, which are pesticides, shall be determined on a case-to-case
basis after consultation with FPA.
67
Formulator’s Exemption. While appropriate data are needed
for the registration of manufacturing-use product, a formulator who
proposes to purchase a registered pesticide from another producer to
formulate such purchased pesticide into an end-use product would not be
required to submit or cite data pertaining to the safety of such purchased
product. This guideline is based on the expectation that it would be the
registrant of the manufacturing-use product who would provide significant
amounts of data pertaining to the safety of its product.
3.2.2 Approach to Testing
To meet the intent of the above policy, the following elements

comprise the approach taken by FPA: exposure criteria (for
biochemicals), maximum hazard testing, and a tier testing scheme.
A. Exposure Criteria
There are certain factors often associated with biochemical

pest control agents or their use that significantly limit the agents’
potential for human and other non-target organism exposure and,
therefore, hazardous. Any or all of these factors provide the basis
for reduced data requirements. These factors are: low exposure
from pesticide formulation, low rate of application, non-aquatic use
site, and high volatility.
B. Maximum Hazard Testing
The concept of maximum hazard testing is used in both the

toxicology and non-target organism sections. The concept
provides for the most challenging exposure in terms of the
treatment dose or concentration, route of administration, and the
age of the test animals used in the first tier of testing. Using this
approach, negative test results obtained would provide a high
degree of confidence that no adverse effects would be likely to
occur from the use of the biorational pest control agents.
C. Tier Testing Scheme
The tier testing scheme is used to ensure that only the

minimum data necessary to make a scientifically sound regulatory
decision are generated. This scheme eliminates the need for
submission of extensive data for those pesticides that are
determined to be safe on the basis of Tier I data. It is expected
that many biorational pesticides would require only Tier I testing.
The Tier Testing Scheme is discussed in detail in Section 3.4.
68
3.3 PRODUCT SPECIFICATION DATA
3.3.1 Scope of Product Analysis Requirements
The product analysis data for biorational pesticides closely parallel

those for conventional chemical pesticides as specified in Table 2.
However, important differences exist due to the unique nature and mode
of action of biorationals as noted below.
3.3.2 Guidelines for Biochemical Pest Control Agents
For this group, the data requirements parallel those required for
conventional chemical pesticides in terms of the detailed information on
the procedures by which the active ingredient is produced, and the
techniques used to ensure a uniform or standardized product. If the
standardization techniques include methods of bioassay, then these
methods shall be described. Particular interest is given to the ingredients,
which may be toxic or sensitizing to humans or other non-target species.
The following are the guidelines for product analysis for this group:
A. Product Identity
Each application for the registration of a biochemical PCA

that is a pesticide product shall contain the product name and the
trade name(s) (if different). The company code number(s) may be
given.
B. Confidential Statement of Formula
An application for registration of a product shall contain a

confidential statement of formula. A separate confidential
statement of formula is required for each alternate formula of a
product. The appropriate FPA form shall be used.
C. Information on Ingredients
An application for registration shall contain the following

information (if available) on each ingredient, which is listed in the
confidential statement of formula required by paragraph (B) of this
section:
1. Each biochemical (including microbial toxins) shall be

identified by:
a. The chemical name(s) from the Chemical Abstracts

1972-1976 Index of Nomenclature, or other well-
defined name;
b. The Chemical Abstracts Service (CAS) Registry

Number(s);
69
c. The structural formula(s), empirical formula(s);
d. The count of biochemical present in the product in

recognized units of potency or other appropriate
expression of biological activity or percentage by
weight;
e. The genus and species names of the organism(s)

from which the biochemical was separated or with
which it is commonly associated; and
f. The specificity or host range of the biochemical

activity and mode of action. With respect to mode
of action of the biochemical, the applicant should
discuss any potential hazard to man, the
environment, or non-target species.
2. Ingredients, other than biochemicals, shall be identified by;
a. Percentage composition (by weight) of each

ingredient;
b. Whether the ingredient is an active ingredient,

intentionally added, or an impurity;
c. The chemical name for the Chemical Abstracts or

other well-defined name;
d. The CAS registry number;
e. The product name, the trade name, and the

common name (if established);
f. The experimental or internal code number;
g. For each active ingredient other than the

biochemical, the empirical formula, and the
molecular weight or the molecular weight range;
and
h. The structural formula, if it can be determined.
3. The composition limits shall be given for each ingredient

for which limits are required to be certified. If space
permits, this information can be listed in the confidential
statement of formula; otherwise, a separate statement on
certification of limits must be submitted.
70
D. Manufacturing Process
Each product’s registration application shall be supported

by an accurate and current description of the process used to
manufacture or formulate the product. The description shall
contain the following information:
1. Basic manufacturing process for each biochemical derived

from biological sources:
a. The starting material shall be listed;
b. The steps taken, both chemical and biological, to

ensure the integrity of the starting material and to
limit the extraneous contamination in the
unformulated biochemical shall be given;
c. The procedures by which the manufacturer

established the identity and purity of the seed stock
from which the unformulated biochemical is
produced shall be described; and
d. The quality control methods and the techniques

used to ensure a uniform or standardized product
shall be reported. Unless the quality control
methods are well established and recognized, they
shall be submitted in detail with information
regarding their accuracy, sensitivity, and the
interfering substances.
2. Toxic or sensitizing substances. If the presence of

ingredients toxic or sensitizing to humans or other non-
target mammalian species is suspected at any stage of the
manufacturing process, then data shall be submitted to
show that the substances do not exist in the final
biochemical product or exist only in quantities too small to
pose any hazard.
E. Discussion on the Formation of Unintentional Ingredients
A registration application shall include a discussion

concerning potential formation and presence of unintentional
ingredients in the product in quantities that may produce adverse
human or environmental effects. Such unintentional ingredients
may be introduced during the manufacturing process with the
starting material, process solvents, equipment, packaging, and
other sources; from side reactions in the manufacturing process;
from interactions between ingredients; and from the degradation
of ingredients. The applicant shall base his discussion on
established chemical theory. For biochemicals, the unintentional
71
ingredients can include but are not limited to extraneous host
residues and residues of contaminants that remain following the
extraction or purification process.
F. Analysis of Samples
A report on the results of preliminary analysis is required to

support the registration of each manufacturing-use product and
those end-use products produced by an integrated formulation
system.
G. Analytical Methods for Certified Ingredient Limits
Information concerning analytical methods to verify

certified limits is required to support the registration of each
manufacturing-use and end-use product.
H. Physical and Chemical Properties
Data on physical and chemical properties are required to

support the registration of each manufacturing-use product and
each end-use product. These data are listed in Table 5..
3.3.3 Product Analysis Guidelines for Microbial Pest Control Agents
For this group, due to the unique nature, composition, and mode
of action of microbial agents, data requirements differ in some respects.
For example, bacteria, fungi, protozoa, and viruses shall be identified to
the extent possible by taxonomic position, serotype, composition, and
strain, or by any other appropriate specific means. This information
would take the place of chemical name and structural formula for
conventional pesticides. As a result, certain portions of the data
requirements table (Table 6.) do not apply. There must be assurance,
however, that the methods used and the data submitted are capable of
demonstrating that the biorational pesticide used in the field is the same
as that which was tested for safety.
A. Product Identity
Each application for registration of a microbial pest control

agent shall contain the product name and trade name(s) (if
different). The company code number(s) may be given.
B. Confidential Statement of Formula
Application for registration of a product shall contain a

confidential statement of formula. This statement shall include the
nature and quantity of diluents and the identity and purpose of
72
inert ingredients such as ultraviolet screens, stickers, spreaders,
and other such materials.
C. Information on Ingredients
Information on ingredients is required to support each

application for registration.
1. The identification of bacteria, protozoa, viruses, or fungi in

the product shall (to the extent possible) include the
following:
a. The taxonomic position, serotype, and strain, or

any other appropriate designation. The precise test
procedures and criteria used for identification (i.e.,
the morphological, biochemical, analytical
(physical, chemical), serological, or other
identification means) and the results of such tests
should be provided;
b. The common, alternative, and superseded names;
c. The natural occurrence of the organism, its

relationship to other species (particularly those that
are pathogenic), and its history; and
d. A description of any unusual morphological,

biochemical, or resistance characteristics of the
organism if such characteristics are different from
the classic description of the organism.
2. An application for registration shall contain the following

information on each ingredient, other than the microbial
agent, listed in the confidential statement of formula
required in item B of this section which is known to be
present or which might reasonably be identified in the
pesticide products.
a. Percentage composition (by weight) of each

ingredient;
b. Whether the ingredient is an active ingredient, an

intentionally added ingredient, or any impurity;
c. The chemical name from the Chemical Abstracts

1972-1976 Index of Nomenclature, or other well-
defined name;
d. CAS Registry Number;
73
e. The product name, the trade name, and the
common name (if established);
f. The experimental or internal code number;
g. For each active ingredient other than the microbial

agents, the empirical formula, and the molecular
weight or the molecular weight range;
h. The structural formula (when known);
i. The composition limits for each ingredient for which

limits are required to be certified. This may be
included in the confidential statement of formula;
j. The amount of microbial agent present in the

product in recognized units of potency, percentage
of weight, units of viability or replication, or other
appropriate expression of biological activity; and
k. The biological properties of the active agent with

respect to target species, pest host range, life
cycle, and mode of action. With respect to the
properties of the microbial agent, any potential
hazard (such as ineffectivity) to man, the
environment, or non-target species should be
discussed.
D. Manufacturing Process
Each application for registration of a manufacturing-use or

end-use product shall contain a description of the basic
manufacturing process. The starting and intermediate materials
shall be listed together with the steps taken to ensure the integrity
of these materials, and the steps taken to limit the extraneous
contamination, both chemical and biological, in the unformulated
microbial agent. This description shall include the procedure used
by the manufacturer to establish the identity and purity of the
culture from which the unformulated microbial agent is produced,
the method of manufacture, and the techniques used to ensure a
uniform or standardized product. The integrity of the product as
determined by the most specific and sensitive chemical or
serological test must be demonstrated. If the test is not a
recognized standard test, a detailed description of the test
together with information regarding specificity, interfering
substances, accuracy and sensitivity must be provided.
74
E. Certification of Ingredient Limits
Each registration shall be supported by a certification of

ingredient limits. The limits for microbial agents shall also be
expressed in terms such as international units of potency per
milligram when these are determined in serological or other
appropriate tests.
F. Physical and Chemical Properties
When required, data on physical and chemical properties

must be submitted to support the registration of each
manufacturing-use product and each end-use product. Take note
of the formulators’ exemption from the submission of the required
data.
3.4 TOXICOLOGY
3.4.1 Major Concerns
Biorational pesticides affect pest populations by controlling

physiological processes, by altering behavior, by competing for space and
nutrients, by parasitizing and lysing the pest, or by replicating in an
ineffective process to cause disease so that the pest is destroyed. The
testing for registration of the product and the kinds of data developed
must be sufficient to allow scientific experts to assess the potential
hazards associated with the use of biorational pesticides.
The major concerns with respect to toxicology are:
1. “infectivity” - the potential for the microorganism to survive

and replicate in a human host. Related concerns include
persistence, invasiveness, colonization, and other host-
parasite interactions.
2. “virulence-toxicity” - the potential for direct injury at the

cellular, tissue, or organ level. Included are the long-term
effects associated with oncogenicity, carcinogenicity, and
teratogenicity.
3. “hypersensitivity” - an immune response leading to an

abnormal sensitivity. Serious reactions include allergies and
anaphylaxis.
These concerns must be addressed in terms of the potential

impact of these agents on the population as a whole particularly on those
persons with altered defenses who might encounter these agents, and
who represent a sub-population at higher risk. At present, viruses are of
particular concern because they generally exhibit a greater incidence of
genetic change than other living forms.
75
Because the field is new, many problems related to toxicology and
hazard evaluation would undoubtedly be encountered. It is recognized
that for some biorational pesticides, there are no well-recognized and
standard test methods for assessing the toxicological hazards to
mammals. When problems arise, the registrant is urged to discuss the
matter with FPA so that alternative methods and protocols can be
considered prior to the actual conduct of the tests.
3.4.2 Biochemical Agents
Testing of biochemical agents for possible effects on humans and

domestic animals is performed in a tier sequence. The potential for
adverse effects can be ascertained by acute toxicity, irritation and
hypersensitivity tests, by short-term mutagenicity tests, and by cellular
immune response studies. When detrimental effects are found in the first
tier of tests, additional studies at the Tier II and III levels shall be required.
The Tier sequence and studies involved are outlined in Table 5.
3.4.3 Microbial Agents
The testing of microbial agents for possible effects on humans and

domestic animals is performed in a tier sequence. These tests consist of
acute toxicity/infectivity studies, cellular immune response studies, and
irritation, hypersensitivity, virulence enhancement, tissue culture,
teratogenicity, mutagenicity, sub-chronic, and chronic studies. Not all
studies pertain to each organism at each tier. The general tier sequence
and studies involved for microbial agents are outlined in Table 6..
3.4.4 Toxicology Data Guidelines for Biochemical Agents
A. Tier I Testing
Guidelines are contained in the following reference documents:
Sub-series 152A, Sections 152-10 to 152-18, pp. 117-129. EPA

Pesticide Assessment Guidelines, Subdivision M Biorational
Pesticides.
B. Tier II Testing

Pesticides.
76
C. Tier III Testing

Pesticides.
3.4.5 Toxicology Data Guidelines for Microbial Agents
A. Tier I Testing

Pesticides.
B. Tier II Testing

Pesticides.
C. Tier III Testing

Pesticides.
3.5 RESIDUE ANALYSIS
3.5.1 Biochemical Pest Control Agents
A. Approach
The full set of residue chemistry guidelines for

conventional pesticides may not always be applicable to
biochemical pest control agents for the following reasons:
1. Biochemical agents occur naturally in the environment or

are identical to naturally occurring biochemicals and have
properties similar to their natural counterparts;
77
2. Many biochemical agents are used at very low application
rates (i.e., <50 g active ingredient or less per hectare); and
3. Past experience indicates that biochemicals are relatively

non-toxic.
Consequently, the resulting residues of biochemicals in

food or feed would be very low and the potential for adverse
effects would be correspondingly low. Thus, it is expected that
significant human dietary exposure will generally not occur from
the use of biochemicals.
B. Tier Progression
In general, when no potentially adverse effects are

observed during the Tier I toxicity testing, a biochemical would be
exempted from the need for a tolerance level, provided it is
applied at rates of 50 g or less active ingredient per hectare per
application. In this situation, FPA would waive the usual
metabolism and residue data and would recommend that an
exemption from the requirement of a tolerance level be made.
On the other hand, the full range of residue chemistry data

required for conventional pesticides would apply to:
1. All biochemical agents proceeding to toxicity testing

beyond Tier I (that is, to Tier II or III); and
2. All biochemical agents to be applied on food or feed crops

at a rate greater than 50 g active ingredient per hectare
per application.
These would include plant metabolism studies, residue

data, and analytical methodology. In addition, depending on the
level of residue found in animal feed, the Agency may solicit data
on animal metabolism and feeding studies to determine the
carryover of residues in meat, milk, poultry, and eggs. When
appropriate, tolerances for the latter commodities would be
necessary.
A. Approach
As with a biochemical agent, the use of a microbial agent

on food, feed, or raw agricultural commodities requires that a
tolerance, or an exemption from the requirement for a tolerance,
be established. In considering exemptions from the requirement
for tolerances, the FPA recognizes that these agents do not
78
necessarily pose the same potential hazards as conventional
chemical pesticides. In fact, certain characteristics of many of
these agents suggest that they pose relatively less hazards.
These characteristics are described below:
1. The efficacy of the agent often depends upon its ability to

replicate in the target pest which is not likely to remain on
the crop after harvest;
2. The living form of the agent in most instances will usually

not replicate in the absence of the specific target pest (e.g.
insect host);
3. Certain environmental conditions such as high sunlight

intensity, heavy rainfall, strong wind, low humidity, and
high temperature often greatly reduce the viability of the
agent and, therefore, the residues of living organisms are
apt to be small or relatively insignificant shortly after
application;
4. When evaluated by the tier testing scheme, data

supporting currently registered microbial agents indicate
that microbial pest control agents would not likely pose a
hazard to human or other animals;
5. In many instances where and when a microorganism is

used as a microbial pest control agent, the microorganism
is already normally present in the environment and has
demonstrated no adverse effects; and
6. Residues of microorganisms used as microbial pest control

agents that are capable of replication on food or feed (a
very remote possibility) will possibly be rendered nonviable
or be removed by the usual processing of such foods and
feeds (i.e., washing, drying, heat sterilization, and addition
of sugar, salt, and other preservatives).
B. Tier Progression
Residue data for microbial pest control agents used in

food, feed, or raw agricultural commodities shall only be required if
toxic or other harmful properties were observed in the maximum
hazard toxicology tests (Tier I). If Tier I toxicology tests indicate
no toxic or other harmful properties, then no residue data would
be indicated and thus a recommendation for an exemption from
the requirements of a tolerance can be made.
Furthermore, it may be stated in passing that, in many

cases, a natural population of microbial agent may be present at
some background level at the site where a microbial pest control
79
agent is applied. It may be impossible, therefore, to distinguish
between natural and introduced microbial populations and thus,
be very difficult to establish and enforce tolerances for naturally
occurring microbial agents. This is something that must be
considered regarding this section.
3.6 NON-TARGET ORGANISM HAZARD
The purpose of non-target organism testing is to generate data necessary

to assess potential hazard of biorational pesticides to terrestrial wildlife, aquatic
animals, plants, and beneficial insects.
3.6.1 Biochemical Agents
A. Terrestrial Wildlife
1. Approach. Hazard evaluation of biochemical agents would

be similar in approach to that of conventional chemical
pesticides. However, the number of Tier I tests would be
lower and the test design modified based on the following
considerations; Tier I tests would be designed to determine
whether LC50 or LD50 values are above a specified
maximum test concentration or dose rather than require
that the LC50 or LD50 be determined. This modified test
design would apply if death was not observed at the
maximum concentration or dose.
This approach is deemed appropriate based on the

following:
a. Innate toxicity is not inherent to the nature and

mode of action of biochemical agents;
b. Experience so far indicates that most of these

pesticides will be applied at very low rates
compared to conventional chemical pesticides,
thereby reducing likelihood or significant exposure
to non-target organisms; and
c. Past experience likewise indicates that most

biochemical pest control agents are not acutely
toxic (e.g. LC50 and LD50 values in Avian species of
most biochemical agents are greater than 5000
ppm or 2000 mg/Kg, respectively).
Both terrestrial wildlife and aquatic animal testing

schemes use some or all of the exposure criteria,
i.e., low use rate, low exposure formulation, non-
80
aquatic use site, and high volatility, to screen out
those pesticides that qualify for reduced testing.
2. Tier Progression. The following criteria are provided for

determining the need for testing a biochemical agent
beyond the first tier:
a. If signs of abnormal behavior are reported in Tier I

tests at levels equal to or less than the maximum
expected environmental concentration; or
b. If detrimental growth, developmental, or

reproductive effects can be expected, based on:
a) Tier I test data; b) available fate data from the
product’s research and development; c) use pattern
information; d) results of mammalian testing
required in the Toxicology section; and e) the
phylogenetic similarity between target pest and
non-target organism; or
c. If the maximum expected environmental

concentration is equal to or greater than 1/5 the
LC50 values established in Tier I terrestrial wildlife
studies, or equal to or greater than 1/10 the LD50 or
LC50 values established in Tier I aquatic animal
studies.
In addition, both Tier I and Tier II tests would be

required if:
• The pesticide is to be applied directly to water;

or
• High use rates are proposed; and
• The biochemical agents are not volatile.
3. Major Issues. In the process of developing testing

guidelines for terrestrial and aquatic animals, there are at
least two (2) areas that need consideration and discussion,
namely:
a. Maximum test concentrations and doses. As part

of the registration requirements, bioassay tests
involving maximum test concentration or dose on
one terrestrial animal (e.g. Avian toxicity oral and
dietary tests) or aquatic organism should be
submitted. Negative results from such tests would
provide a high degree of confidence that no
adverse effects are likely to occur from the actual
use of the biochemical pesticide. If, however,
effects are observed at these maximum levels, then
81
further testing at lower levels would be indicated in
order to establish precise LC50 and LD50 values and
corresponding 95 % confidence limits.
Regarding the calculation of the maximum test

concentrations, the general equations proposed by
US EPA are as follows:
Maximum application rate

*
Maximum Test = in grams AI per acre x 2000 mg/Kg
**
Dose 454
Maximum application rate

*
Maximum Test = in grams AI per acre x 5000 ppm
**
Concentration 454
For example, a 20 gram/acre (49 gram/hectare) rate would

give an 88 mg/Kg maximum test dose and a maximum test
concentration of 220 ppm.
b. Categorization of semiochemicals by structure

/activity relationships. Categorization of chemicals
is a method through which scientists can infer
which chemicals present risks or harm to humans
and to the environment. The study of
structure/activity relationships (SAR) seeks to find
association between a substance physical and
chemical properties and its effect on biological
activity. Use of SAR in the assessment of adverse
effects of some industrial chemicals to non-target
organisms, such as shrimp and clams, had been
reported (Mcleese et al, 1979). Since most
semiochemicals used as pesticides are applied at
very low rates and possess special
physicochemical properties (such as high volatility)
that lessen their exposure to terrestrial animals,
acute toxicity data on terrestrial animals for each
new semiochemicals submitted for registration may
not be necessary. Rather, a determination of
hazard could be based on existing acute toxicity
data for structurally similar semiochemicals.
These guidelines for biochemical pesticides do not

include use of structure/activity relationships.
However, the concept when developed for
semiochemicals could provide an acceptable
database for hazard assessment concerning both
terrestrial and aquatic animals. At the same time, it
*
For biochemical pest control agents.
**
A typical application rate for conventional pesticides.
82
could reduce the data required for registering
semiochemicals used as pesticides.
B. Aquatic Animals
Regarding risks to aquatic animals, many biochemical

agents possess special physicochemical properties, or are applied
in a manner such that they are unlikely to enter the aquatic
environment in significant quantities. Consequently, they would
not be expected to pose hazards to aquatic animals. On this
basis, the guidelines are reduced to two ways:
1. The fish acute bioassay test indicated that only one fish
species, rather than two, be tested; and
2. One control group and one treatment group per test may
be all that are necessary to provide satisfactory data
showing no adverse effects.
Moreover, it is expected that each biochemical screened

out for reduced testing would have several criteria supporting such
a course of action such as: i) non-aquatic use; ii) low potential for
significant exposure based on use pattern and formulation; iii) low
use rate; and/or iv) high volatility.
C. Non-Target Plants
1. Approach. The testing procedures for biochemical agents

should be similar to those for other chemical pesticides
with respect to phytotoxicity studies.
2. Tier Progression. Progression to Tier III and further plant

effects testing would depend on whether there are any
adverse effects to desirable plants at the Tier I level, and
whether there is possible movement by soil, water, or air
from the intended site of application to non-target areas as
determined by selected tests of Tier II on environmental
fate. In the vast majority of biochemical pesticides, such
movement might occur, but as levels far below those which
would have a detrimental effect as determined in the Tier I
tests.
D. Non-target Insects
1. Approach. Development of baseline (first tier) tests for

biochemical pesticides is difficult, for the following two
reasons:
83
a. Effects of these biochemicals will often be long-
term (e.g. effects on growth) rather than acute; this
type of activity does not lend itself to short term
testing; and
b. Effects on development or behavior, unlike

mortality, may be difficult to quantify.
In view of the above, no outline for any specific types of

Tier I testing for effects of biochemical pesticides on non-
target insects will be prescribed. Rather, the registrant
should report any adverse effects on non-target insects
noted during efficacy testing, including effects such as:
a. Mortality or other adverse effects (e.g. behavioral

modification) on insect predators or parasites of the
target organism; and
b. Direct adverse or repelling effects on pollinators.
2. Tier Progression. As noted above, no Tier I testing shall

be required. Rather, Tier I shall consist of data (such as
efficacy data) submitted by the registrant or made available
from another source. If no such effects are noted during
efficacy testing, and in the absence of any other data
indicating potential for adverse effects, no non-target
insect testing will be indicated. However, if adverse effects
are noted and/or auxiliary data indicate a potential for
adverse effects, then Tier II (Environmental Fate) testing
shall apply. If fate do not indicate exposure, no further
testing shall be indicated. If fate testing indicates
exposure, the registrant shall consult with the FPA
regarding further testing at the Tier III level. Testing
required at this point would most likely be simulated or
actual field-testing.
A. Terrestrial Wildlife and Aquatic Animals
1. Approach . Pathogenicity and toxicity are the major effects

of concern regarding terrestrial and aquatic organisms.
Therefore, guidelines that will allow hazard assessment of
possible pathogenicity and toxicity problems are needed.
In addition, it is desirable to have a high level of confidence

that no adverse environmental effects will result from
actual use of microbial pest control agents. Toward this
end, the guidelines in Tier I reflect a maximum hazard
84
approach to testing as described earlier. Prior to
registration of naturally occurring and strain-improved
microbial agents, applicants would submit only Tier I data
on non-target organisms. However, for the registration of
genetically engineered microbial pest control agents, both
non-target organism data (Tier I) and environmental
expression data (Tier II) would be evaluated.
2. Major Issues
a. Maximum hazard dosage levels. The

environmental levels of microbial PCAs and any
associated toxins are expected to increase at least
temporarily when the product is effective.
Therefore, the maximum hazard dose for Tier I
testing will be based on some safety factor times
the maximum amount of active ingredient (microbial
agent or its toxin) expected to be available to
terrestrial and aquatic plants and animals in the
environment. The target hosts (e.g. insects) are
likely to contain the highest concentration of the
microbial pest control agent that will be available to
non-target terrestrial wildlife and aquatic animals
following a pesticide application. The maximum
amount of microbial pest control agent (active
ingredient) that one infected host can contain is
called the host equivalent in this guideline. The
maximum hazard dose is equal to the host
equivalent multiplied by the ratio of the weight of
the test animal (e.g., fish or bird) to the weight of
the infected host organism (e.g., insect larva). The
route(s) of administration (e.g., oral or parenteral)
and the size of the test organism(s) will largely
determine whether the maximum hazard dose will
be a multiple or a fraction of the adjusted host
equivalent amount.
In the case of microbial pest control agents applied

to the soil to control soil-borne diseases affecting
plants, the soil may contain the highest
concentration of the agent. The host equivalent
concept would not be applicable in this situation
since the host, most often, will be a microscopic
propagule (a spore, oospore, sclerotium or
chlamydospore).
Because test data are not likely to exhibit a log-

prohibit dose-response relationship that is typical of
chemical pesticides, it would be very difficult to
establish specific LC50, ED50, or LD50 values (e.g.,
85
LD50 = 1000 mg/Kg) and 95 % confidence limits for
most microbial pest control agents. Therefore, the
data establishing that the LD50, ED50, or LD50 is
greater than the maximum hazard dosage level
(e.g., LD50>1000 mg/Kg) would often be adequate
for purposes of hazard assessment. In most cases,
testing at one maximum hazard dosage level is
expected to be sufficient to evaluate effects.
b. Maximum hazard routes of administration. The

parenteral route (e.g. intravenous (IV),
intraperitoneal (IP) is considered an appropriate
method for conducting maximum hazard exposure
to terrestrial and aquatic animals in Tier I tests.
Negative test results obtained using this method
and using maximum hazard dosage levels would
provide a high level of confidence that no adverse
effects would occur from the actual use of the
microbial PCA.
c. Age of the test animals. For Tier I tests, the use of

immature animals as test organisms is
recommended in keeping with the maximum hazard
approach to testing.
d. Method for detecting effects. Due to the extremely

diverse nature of the active component in microbial
PCAs (e.g., natural toxins, acellular agents
(viruses), prokaryotic cells (bacteria), eukaryotic
cells (fungi, protozoans, most algae), many
different methods to detect each agent and assess
infections have been developed. To assist
applications and registrants, the Agency is
providing a scheme which will show some
acceptable methods for detecting pathogenic
effects for each type of microbial agent (Table 8.).
B. Aquatic Animals
1. Approach. The criteria identified to determine the extent of

testing for effects on aquatic animals in Tier I are the
following:
a. Site of application and resulting potential for aquatic

exposure;
b. The natural geographic distribution of the

microorganism;
86
c. The natural population level of the microorganism
compared with population levels likely after
application;
d. Ability of the microbial pest control agent to survive

and replicate after application; and
e. The extent to which the microorganism has been

manipulated or genetically engineered.
2. Tier Progression. Tier I. For microbial PCA applied in

terrestrial use patterns where no direct aquatic exposure is
anticipated, one freshwater fish and one freshwater
invertebrate shall be tested to assess toxicity and
pathogenicity. For microbial PCA applied directly to
aquatic bodies, one additional fish species and one
additional invertebrate species shall be tested. These
tests shall be conducted as 30-day static or static renewal
bioassays using one or a combination of methods to
administer the pesticide (e.g., aqueous, dietary, or
injection).
No further testing shall be indicated if: (1) results of the

aforementioned tests indicate no toxic or pathogenic
effects; and (2) host spectrum or beneficial insect tests
indicate that the microbial pest control agent has a narrow
host spectrum such the crossover into non-target aquatic
invertebrates is not likely. If toxic or pathogenic effects are
observed, then environmental expression testing (Tier II)
would follow. If crossover into non-target aquatic
invertebrates are implied, then additional aquatic
invertebrates species would have to be tested in Tier I or
Tier II testing would have to be conducted.
All genetically engineered microbial agents would be

subjected to Tier II testing. Tier III and Tier IV testings
should they become necessary must be consulted with the
FPA.
C. Non-target Plants
1. Approach. While phytotoxicity data for conventional

chemical and biorational biochemical pesticides will be
required only on a case-to-case basis, it seems
appropriate that phytotoxicity studies be submitted for all
microbial pest control agents. The pesticide science for
these agents is relatively new and their adverse effects can
be far-reaching. These effects may occur because
microbe is capable of extensive regeneration in a favorable
environment. If it is transported to other off-target areas
87
and the selectivity is not known, considerable damage to
desirable plants can occur.
2. Major Issues. The primary concerns with respect to the

use of living organisms on or near desirable or non-target
plants in the control of pest plants are the selectivity of the
organisms, the purity of the organism or strain produced
(quality control), and the persistence or lack thereof of the
organism. There are several criteria that must be satisfied
in varying degrees in order for the pathogen to be
desirable candidate as a biological control agent for
pestiferous plant species. These criteria include:
a. Selectivity for the specific pest organism;
b. Absence of adverse effect on man; domestic

animals, fish, wildlife, and desirable insects;
c. Absence of adverse effect on non-target or

desirable plants;
d. Absence of any detrimental effects on water quality;
e. Lack of accumulation in non-target organisms;
f. Ease of production, dissemination, and self-

maintaining capability when established;
g. Effectiveness under the environmental conditions of

the intended use locations; and
h. Simplicity of assay for its presence in small

amounts both quantitatively and qualitatively.
Similarity of testing procedures to those recommended for

the previous groups should be followed, otherwise consult
the FPA on this.
D. Non-target Insects
1. Approach. Most microbial pest control agents shall be

specifically selected and/or designed for their ability to
control pest insects. As such, non-target insects represent
the organism group most at risk in most cases, relatively
closely related to the target insects. Unlike chemical
pesticides, most microbials will work through pathogenicity
rather than toxicity. Adequate assessment of pathogenicity
will demand time to evaluate the microbial agent for
infectivity and for its ability to reproduce or develop in the
test insect.
88
2. Tier Testing. The purpose of the Tier I testing is to assess
toxicity and pathogenicity of the microbial agent to
representatives of a few major orders of beneficial insects.
In this case, the honeybee and three species each of
predaceous or parasitic insects. Selection of the
predator/parasite species to be tested shall take into
account such factors as the likelihood of exposure to the
microbial agent, phylogenetic proximity of the test species
to target pest species and similar relationships. Rationale
for selection shall be provided by the registrant. Data
derived from Tier I testing shall be in conjunction with
available information on use pattern, host range
(specificity), fate, and other similar factors, to assess
potential for adverse effects. If the results of Tier I testing
indicate toxic and/or pathogenic effects, the Tier II testing
(environmental expression) would follow, otherwise no
further test is required.
For all genetically-engineered microorganisms, however,

testing includes appropriate Tier I tests and Tier II
(environmental) testing.
Tier III. For all microbial pest control agents, Tier III consists
of advanced tests specifically responding to adverse effects
identified in earlier tier testing. Such tests may be simulated
or actual field tests are done. In any case, Tier III testing
would be preceded by consultation with FPA.
3.7 ENVIRONMENTAL FATE AND EXPRESSION
3.7.1 Biochemical Pest Control Agents: Environmental Fate Testing
A. Scope and Approach
The term environmental fate pertains to biochemical pest

control agents (whereas, the term environmental expression pertains
to microbial pest control agents). The purpose of environmental fate
testing is to generate the data necessary to estimate the
concentration of a biochemical pesticide and its degradates occurring
in or on various media (i.e., soil, water, air) at intervals after pesticide
application. Generally, these data would be submitted if adverse
effects are observed in Tier I environmental effect tests or if the
biochemical is applied directly to water. Figure 3 outlines the
Environmental Fate Testing Scheme.
89
Figure 3. ENVIRONMENTAL FATE TESTING SCHEME
Potential adverse effects are seen in Tier I Testing. (If not, no testing is indicated
in Tier II unless product as aquatic use pattern or biochemical is not applied in a
controlled release device, in which case the process should proceed directly to
Persistence Testing.
TRANSPORT TESTING
Volatility (# 155-4) *
Dispenser Water Leaching (#155-5)
Vapor Pressure (#151-17)*
Water Solubility (#151-17)
Estimated Environmental Concentration (EEC) determination from mass-balance

analysis
EEC indicates potential hazard. (If none, no further testing is indicated.)
PERSISTENCE TESTING
Adsorption/desorption (#155-6)*
Octanol/water partition coefficient (#155-7)
Hydrolysis (#155-9)
Aerobic soil metabolism (#155-11)
Soil photolysis (#155-12)
Aquatic photolysis (#155-13)
Potential for adverse effects to non-target organisms.

(If not, no further testing is indicated.)
Additional non-target organism testing is indicated (Tier III)
*
Number in parenthesis indicate the section series and sub-series number in US EPA Pesticide
Assessment Guidelines, Subdivision M Biorational Pesticides.
90
B. Tier Testing
The Tier II environmental fate testing scheme consists of

twelve (12) separate tests. Seven of these tests are identical to those
described for conventional chemical pesticides. The remaining five
tests are new. These tests (volatility of dispensed product,
dispenser-water leaching, UV (ultraviolet) absorption spectra, bio-
monitoring for degradation products, and bio-monitoring for
disappearance of biochemicals) address some of the unique
properties of biochemical pesticides. Each of these tests is described
in the respective section series/sub-series numbers as shown in
Figure 3.
3.7.2 Microbial Pest Control Agents: Environmental Expression Testing
A. Scope and Definition
The term environmental expression as applied to microbial

pest control agents is defined as the ability of the physiologically
active component of the microbial pest control agent to propagate
and become established in a new niche or host after it has been
introduced (applied). “Expression” is the counterpart of “fate”
which applies to chemical or biochemical pesticides and is defined
as the transport and transformation of a chemical by natural
means after it is released to the environment.
B. Tier Testing
The Tier testing scheme in section series 154 and 155 of

Subdivision M is designed to present the maximum hazard to non-
target organisms in the initial (Tier I) testing of microbial PCA.
Negative results in Tier I mean no further testing is indicated.
However, positive results (toxic or pathogenic effects) observed
shall mandate further testing in Tier II, environmental expression
testing.
Likewise, whenever the agent is a genetically engineered

organism, Tier II is also required.
Tier II consists of screening tests that will eliminate the

need for Tier III testing whenever the results show that the agent
will not become permanently established once applied or
inadvertently inserted into a new niche or host, or cannot
survive except under special conditions (e.g., specific host,
obligatory heterotoph).
91
In Tier II, the agent is tested for ability to persist in a
terrestrial freshwater, marine, or estuarine environment so that
potential exposure of non-target organism can be determined.
Depending on the use pattern, the tests could be a greenhouse
test for determining expression in a terrestrial environment and
two aquaria tests for determining expression in a terrestrial
environment and two aquaria tests for determining expression in
freshwater and in estuarine /marine environments.
3.8 PRODUCT PERFORMANCE DATA REQUIREMENTS
3.8.1 General Provisions
A. Waiver of Data Requirements: Policy
In considering an application for registration of a pesticide,

the Administrator may waive the data requirements pertaining to
efficacy under certain conditions. The FPA is limiting its direct
concern to, and requiring efficacy data for products having health
related use patterns and products proposing new and added uses
of chemicals which have been identified as posing a risk of
unreasonable adverse effects. In keeping with this concern, the
Administrator has deemed it proper that all applications for
products not having a direct impact on public health may have
their efficacy data requirements waived.
B. Efficacy data generally will be required only for products of the

following types:
1. Uses of agents intended to control microorganisms

infectious to man in any area (inanimate surface) where
these microorganisms may present a health hazard; and
2. Uses of agents intended for control of fungal organisms

that produce aflatoxins.
C. Data on phytotoxicity to the target site, i.e., crops or other

desirable plants are considered part of an efficacy evaluation and
are thus waived. On the other hand, data on phytotoxicity to crops
or other plants that are non-target sites are considered to be data
for hazard evaluation and must be submitted on a case to case
basis as prescribed in Section series 154-10 and 14. Data on the
effects of microbial pest control agents on non-target plants must
be submitted for all such products as described in Section series
154-22 and -31.
92
3.8.2 Specific Provisions
The following provisions apply to all biorational pesticides

regardless of whether product performance data are or are not waived in
accordance with the foregoing policy statement.
1. The available information on host spectrum shall be reported;
2. The time required to achieve the desirable level of pest control or

other product performance standard shall be reported; and
3. The minimum effective dosage (MED) necessary to achieve the

desirable level of pest control or other product performance
standard shall be reported.
3.9 EXPERIMENTAL USE PERMIT GUIDELINES
3.9.1 Scope and Intent
This section deals with the data necessary to support the

application for an experimental use permit for a biorational pesticide.
These data generally include those that would ordinarily be developed
first in preparation for product development and registration. For
example, most product analysis information would be developed early in
the product development stages, and the Tier I toxicology and non-target
organism toxicity tests would usually be conducted first in preparation for
registration. Unless these test results indicate toxic, pathogenic, or other
harmful properties, no data on residues or environmental fate would be
necessary. Efficacy data follow the pattern already established in
guidelines for conventional pesticides which waive the requirements for
most products not dealing with public health areas, but the submittal of
data on host spectrum, and time and minimum effective dosage required
to achieve the product performance standard is required.
3.9.2 General and Specific Provisions
A. General Provision
In developing plans and information for experimental use

permit application, the applicant should carefully review the
guidelines for the registration of conventional pesticides which
generally apply to biorational pesticides unless otherwise waived
or noted.
B. Specific Data Requirements
1. Product analysis data - See Section 3.3
93
2. Toxicology Data
The following data are required to support EUP
application:
a. Biochemical Pest Control Agent (PCA) not used on

food crops:
• Acute oral toxicity;

• Acute dermal toxicity;
• Primary eye irritation;
• Primary dermal irritation; and
• Studies to detect gene mutation.
b. Biochemical PCA used on food crops:
• All studies listed above in B.2.a of this section;

and
• Cellular immune response studies.
c. Microbial PCA not used on food crops:
• Acute dermal infectivity;

• Intravenous, intrecerebral, intraperitoneal
infectivity;
• Primary dermal irritation; and
• Primary eye irritation.
d. Microbial PCA used on food crops:
• All studies listed in B.2.c of this section;

• Cellular immune response; and
• Tissue culture with viral agents.
C. Residue Data
For biochemical PCA, residue data are required to support

an application for EUP when the product will be used on food or
feed crops or when its use is expected to result in residues in or
on food or feed and for any of the following situations:
1. The rate of application of biochemical PCA exceeds 50 grams

active ingredient per acre (120 g/Ha) per application; or
2. Tier I toxicology studies conducted under paragraph B.2.b

indicate a potential for human hazard. Residue data
requirements shall be determined on individual basis for bio-
chemicals applied directly to food or feed, and for
biochemicals whose application rate can not be expressed in
grams per hectare per application.
94
For microbial PCA used on food or feed crop or whose use
is expected to result in residues in or on food or feed, no data are
required unless Tier I toxicology studies conducted under B.2.d of
this section indicates a potential for human hazard.
D. Non-target Organism Toxicology Tests
To support an application for an experimental use permit,

non-target organism data developed in Tier I studies of
biochemical and microbial pest control agents as described in
Section 3.6 are required.
E. Environmental Fate and Expression Data
To support an application for an EUP, data from

environmental fate and expression studies are required according
to Section 3.7. For those biochemical and microbial PCAs whose
Tier I non-target organism test results indicate that Tier II studies
for environmental fate and expression shall be conducted. For
those PCAs where Tier I non-target organism test results indicate
that no Tier II studies are necessary, no environmental fate and
expression data are required for EUP application. In those
instances where field data from Tier II studies are required for a
permit, any comparable or limited field data would suffice in lieu of
extensive field data; this policy is needed to preclude generation
of extensive field data without a permit in order to obtain
information necessary to get a permit.
F. Product Performance or Efficiency Data
In general, efficacy data shall not be required to support

the issuance of an experimental use permit, except under the
following situations:
1. Initial permits. Efficacy data may be required on a case-to-

case basis for the following use patterns:
• Public health uses dealing with microscopic pest

organisms; and
• Use of cancelled or suspended pesticides.
2. Extensions, renewals, and amendments. Summaries of

product performance data collected under an experimental
use permit may be requested on a case-to-case basis for
the purpose of:
• Determining the need for additional quantities of

product requested by the applicant;
• Evaluating requests for permit extensions; and
• Assessing requests for permit renewals.
95
3.10 PROMOTING BIORATIONAL PESTICIDES
3.10.1 Approach
Consistent with the agency’s mandate to protect public health and

the environment, the FPA is currently pursuing and promoting the
development and use of biological and biologically derived control agents.
The FPA has recognized that biorational pesticides are inherently
different from conventional pesticides and that the fundamentally different
modes of action of biorationals and the consequent lower risks of adverse
effects from their use must be taken into account. Embracing this policy,
the guidelines sought to reduce the burden of extensive data generation
by the introduction of the tier testing concept. This departure from
standard procedures is intended to function as a catalyst for development
of additional innovative control agents consistent with the promotion of
Integrated Pest Management (IPM) and “the safe and effective use of
chemical, biological and alternative methods to combat and control
pests.”
3.10.2 Product Label Guidelines
Public awareness of the unique qualities inherent in biorational

pesticides is an integral element to the successful promotion of these
agents for practical use. One of the more obvious vehicles available for
reaching the public is pesticide labelling. While biochemical agents are
viewed essentially the same as conventional chemical pesticides with
respect to label requirements, labelling for microbial agents differs
principally with respect to the ingredient statement. Also, current labelling
guidelines prohibit “claims as to the safety of a pesticide or its ingredients,
including statements such as ‘safe’, ‘non-poisonous’, ‘non-injurious’,
‘harmless, or ‘non-toxic to humans or pets’...” This could be amended for
biorational pesticides to allow claims as to lack of adverse effect on
beneficial agents critical to IPM and crop production systems when
supported by appropriate data. The lower degree risk inherent in
biorational pesticides shall be discernible through the label signal words
and the relative reduction of precautionary statements. Any amendment
however, must be subject to the guidelines prescribed herein, particularly
Section 3.6, on Non-Target Organism Hazards.
96
Table 5. SUMMARY OF DATA REQUIREMENTS FOR THE REGISTRATION OF
BIORATIONALS (BIOCHEMICAL CONTROL AGENTS)
Technical/
DATA REQUIRED Purer Grade Manufacturing- End-Use
of Active Use Product Product
Ingredient
1.1 Name/Address of Applicant R R R

1.2 Product Trade/Brand Name R R R
1.3 Manufacturer Source of Technical Material R R R
1.4 Description of Manufacturing Process R R R
includes starting material, steps taken, both
chemical and biological, procedures in
establishing identity and purity of feedstock
quality control methods and presence of
toxic or sentisizing substances.
1.5 Method of Analysis R R R
2.0 SPECIFICATIONS
2.1 Common Name R R R

2.2 Chemical Name R R R
Chemical Abstract Registry Number R R R
2.3 Formula (Empirical and Structural) R R R
2.4 Scientific Name Associated Organism R R R
2.5 List of Ingredients, Percent Composition and R R R
Molecular Wt. of each Ingredient, include
impurities (Certification of Composition
Limits for each Ingredient must be
submitted)
2.6 Physical State, Colour, Odor R R R
2.7 Melting Point R (solid) X X
2.8 Boiling Point R (liquid) X X
2.9 Vapor Pressure R (pure form) X X
2.10 Density or Specific Gravity R R R
2.11 Octanol/Water Partition Coefficient R (non-polar, X X
pure organic)
2.12 Solubility R X X
2.13 Stability / Storage Stability R X X
2.14 Flash Point / Flammability X R R
2.15 Flame Extension X X R
2.16 Viscosity X R R
2.17 Miscibility X R (only R (only
emulsifiable emulsifiable
liquids) liquids)
2.18 pH R R R
2.19 Corrosion Characteristics X R R
(when packed (when packed
in metal, plastic in metal, plastic
or paper) or paper)
97
Table 5. (continued)
Technical/
Ingredient
3.0 BIOEFFICACY
3.1 Description of mode of action of active agent X X R

on pest for which control is claimed
3.2 Pest controlled and names of crops, materials X X R
or premises to be protected
3.3 Application rate (Kg ai/Ha or % ai spray X X R
dilution for each site/pest tested)
3.4 Frequency and timing of application for each X X R
site/pest tested
3.5 Method of application X X R
3.6 Phytotoxicity X X R
3.7 Results of laboratory study if any X X R
3.8 Effects on beneficial organisms or non-target X X R
organisms
3.9 Complete description and data from local field X X R
trials or relevant test performed abroad or
request for waiver for each site/pest on label
4.0 TOXICOLOGY (Biochemical Pesticides)
TIER I
4.1 LD50 Determination

Oral (rat) R R R
Dermal (rat, mouse or rabbit) R R R
Inhalation (rat, mouse, rabbit or guinea pig) R R R
4.2 Irritation
Occular, primary (albino rabbit) X R R
Dermal, primary (albino rabbit or guinea pig) X R R
4.3 Hypersensitivity
Immediate (human experience during product X R R
development)
Non-immediate (honesty or albino guinea pig) R R R
4.4 Mutagenicity (microbial organisms, see text) R R R
4.5 Cellular Immune Response (mouse) X X X
TIER II
4.6 Mutagenecity (mamalian cell, see text) R R R

4.7 Subchronic Oral (rat, mouse or dog) R X X
4.8 Subchronic Dermal (rabbit or guinea pig, R X X
species not tested in TIER I)
98
Technical/
Ingredient
4.9 Subchronic Inhalation (rat) R X X

4.10 Cellualar Immune Response (mouse) R X X
4.11 Teratogenecity (two species from rat, R X X
mouse, hamster, rabbit)
4.12 Chronic Exposure (rat) R X X
4.13 Oncogenic (newly weaned rat or mouse) X X X
5.1 Avian Acute Oral Toxicity R X R

5.2 Avian Dietary Acute Toxicity R X R
If need is indicated by Acute Oral
5.3 Fish Acute Toxicity (one species) R X R
5.4 Sub Acute Fish Toxicity R X R
When prolonged exposure is likely; test
period up to 30 days
5.5 Aquatic Acute Toxicity R X R
5.6 Fish Accumulation R X R
When need is indicated by use pattern
5.7 Avain reproduction R X R
If needed is indicated by feeding study
results
5.8 Fish Reproduction R X R
If there is persistent exposure indicated by
use pattern and persistence
5.9 Acute Toxicity to Honeybees R X R
If use involves crops where bees are present
during and just after spraying
5.10 Contact Toxicity to Honeybees R X R
If exposure and acute test shows high bee
toxicity
5.11 Soil non-target microorganisms R X R
If high soil concentration is expected from
use
5.12 Soil non-target macroorganisms R X R
use
99
Technical/
Ingredient

EXPRESSION *
6.1 Volatility R R R
6.2 Adsorption/Desorption R R R
If pesticide like to raech soil or water
6.3 Leaching R R R
6.4 Degradation in soil R R R
If pesticide is likely to raech soil
6.5 Biodegradation R R R
6.6 Hydrolyses R R R
6.7 Aqueous photolysis R R R
6.8 Ultra Violet Absorption Spectra R R R
6.9 Biomonitoring for Degradation Products R R R
6.10 Biomonitoring for Disappearance of R R R
Biochemicals
6.11 Analytical Method for Residues in Soil R R R
6.12 Analytical Method for Residues in Water R R R
7.0 LABELLING
7.1 Proposed Toxicity Category R R R

7.2 Draft Label R R
*
Require only if TIER I Environmental effects showed adverse effects or if organism is
genetically engineered.
100
Table 6. SUMMARY OF DATA REQUIREMENTS FOR THE REGISTRATION OF
BIORATIONALS (MICROBIAL PEST CONTROL AGENTS)
Technical/
Ingredient
1.1 Name/Address of Applicant R R R

1.2 Product Trade/Brand Name R R R
1.3 Company Code Number R R R
1.4 Manufacturer Source of Microbial Material R R R
1.5 Confidential Statement of Formula R R R
(includes nature and quantity of diluents and
other ingredients)
1.6 Description of manufacturing process R R R
includes starting and intermediate materials,
steps taken both chemical and biological, in
unformulated microbial agent, procedures
used in establishing identity and purity of
product, quality control methods and
presence of toxic sensitizing substances
1.7 Methods of Analysis R R R
If not standard, provide detailed description
2.0 SPECIFICATIONS
2.1 Identification of Organism (bacteria,

protozoa, viruses or fungi in the product)
• Taxonomic position, stereotype and R R R
strain
• Test procedure used for identification R R R
• Common alternative or superseded R R R
names
• Natural occurrence and history of R R R
organism
• Description of any unusual R R R
morphological and biochemical
characteristics
2.2 List of Ingredients – Percent composition, R R R
whatever active, intentionally added or
impurity
• Chemical name and CAS number R R R
• Empirical and/or structural formula R R R
and Molecular Wt. or Mol. Wt. Range
• Composition limits for each ingredient R R R
• Amount of microbial agent in the R X R
product in recognized units of
potency, weight percent, etc.
101
Technical/
Ingredient
2.3 Physical State, Color, Odor R R R

2.4 Density of Specific Gravity R R X
2.5 Stability R X X
2.6 Storage Stability R R R
2.7 Viscosity X R R
(for liquids)
2.8 Corrosion Characteristics X R R
(when packed in metal,
paper or plastic)
3.0 BIOEFFICACY
3.1 Description of mode of action of active agent X X R

on pest for which control is claimed
3.2 Pest controlled and names of crops, X X R
materials or premises to be protected, and
life cycle
3.3 Application rate (Kg ai/Ha or % ai spray X X R
dilution for each site/pest tested)
3.4 Frequency and timing of application X X R
3.5 Method of application X X R
3.6 Phytotoxicity X X R
3.7 Results of laboratory study, if any X X R
3.8 Effects on beneficial organisms or non-target X X R
organisms
3.9 Complete description and data from local X X R
field trials or relevant tests performed abroad
or request
4.0 TOXICOLOGY (Tier Tests on

Microbial Pest Control Agents) *
TIER I
4.1 LD50 Determination
Oral (rat) BFVP BFVP BFVP
Dermal (rat or mouse) BFVP BFVP BFVP
Inhalation (mouse, rabbit or guinea pig) BFVP BFVP BFVP
4.2 Infectivity
Intravenous (newly weaned mouse and B, V
hamster)
Intracerebral (newborn mouse and hamster) V
Intracerebral (mouse and rabbit) P
Intraperitoneal (mouse and rabbit) P
Intraperitoneal (mouse and one other species) F B B
*
B – Bacteria, F – Fungi, V – Virus, P – Protozoa
102
Technical/
Ingredient
4.3 Irritation
Occular, primary (rabbit) B BFVP BFVP
Dermal, primary (rabbit or guinea pig) BFVP BFVP
4.4 Hypersensitivity
Immediate (human experience during product FVP BFVP BFVP
development)
Non-immediate (honesty or albino guinea pig) B BFVP BFVP
4.5 Cellular Immune Response (mouse) FVP
4.6 Tissue Culture (various vell lines, see section V
on viral agents)
TIER II*
4.7 Acute oral (puppies administered large doses) P P
4.8 Acute oral (newly weaned mouse and/or V V
hamster)
4.9 Acute inhalation (a different species than used P P
in Tier I)
4.10 Acute inhalation (newly weaned mouse and/or V V
hamster)
4.11 Acute interperitoneal or intracerebral (two BF
species other than those used in Tier I; half
the group are immunodepressed)
4.12 Subchronic oral (mice, rat or dog; 90 day test) P
4.13 Primary dermal (guinea pig, use dilution doses) P
4.14 Primary occular (rabbit, use dilution doses) BFVP
4.15 Cellular Immune Response (antibody formation BFVP
cell mediated response)
4.16 Teratogenicity tests (two species from rat, BFVP
mouse, hamster, rabbit)
4.17 Mutagenicity tests (mammalian cell, see text) BFV
4.18 Virulence enhancement (mice or hamster, serial BFVP
passage)
TIER III*
4.19 Chronic oral (rat) BFVP
4.20 Oncogenicity test (newly weaned mouse and or BFVP
rat)
4.21 Mutagenicity test (mammals using the expected BFVP
route of exopsure)
4.22 Teratogenicity test (two species from rat, BFVP
mouse, hamster or rabbit)
*
Not all tests may be indicated for each microbial pest control agent, the appropriate tests will depend on
the results of Tier I and/or Tier II tests.
103
Technical/
Ingredient
5.1 Avian Acute Oral Toxicity R X R

5.2 Avian Dietary Acute Toxicity R X R
If need is indicated by Acute Oral
5.3 Fish Acute Toxicity (one species) R X R
5.4 Sub Acute Fish Toxicity R X R
When prolonged exposure is likely; test
period up to 30 days
5.5 Aquatic Acute Toxicity R X R
5.6 Fish Accumulation R X R
When need is indicated by use pattern
5.7 Avain reproduction R X R
If needed is indicated by feeding study
results
5.8 Fish Reproduction R X R
If there is persistent exposure indicated by
use pattern and persistence
5.9 Acute Toxicity to Honeybees R X R
If use involves crops where bees are present
during and just after spraying
5.10 Contact Toxicity to Honeybees R X R
If exposure and acute test show high bee
toxicity
5.11 Soil non-target microorganisms R X R
use
5.12 Soil non-target macroorganisms R X R
use

EXPRESSION *
6.1 Volatility R R R
6.2 Adsorption/Desorption R R R
If pesticide like to reach soil or water
6.3 Leaching R R R
6.4 Degradation in soil R R R
If pesticide is likely to reach soil
6.5 Biodegradation R R R
6.6 Hydrolyses R R R
*
Require only if TIER I Environmental effects showed adverse effects or if organism is genetically
engineered.
104
Technical/
Ingredient
6.7 Aqueous photolysis R R R

6.8 Ultra Violet Absorption Spectra R R R
6.9 Biomonitoring for Degradation Products R R R
6.10 Biomonitoring for Disappearance of R R R
Biochemicals
6.11 Analytical Method for Residues in Soil R R R
6.12 Analytical Method for Residues in Water R R R
7.0 LABELLING
7.1 Proposed Toxicity Category R R R

7.2 Draft/Final Label R R
105
Table 7. SUMMARY OF DATA REQUIREMENTS FOR EUP BIORATIONALS
Types of Data Food Crop Use Non-Food Crop Use

Biochemical Microbial Biochemical Microbial
1.0 GENERAL
1.1 Name/Address of Applicant R R R R

1.2 Product Trade Name X X R R
1.3 Source of Technical Grade Material R R R R
1.4 Material Safety Data Sheet X X R R
2.0 SPECIFICATIONS
Full Specifications required as in R R R R

the Registration of Biorationals
(see Table 3.1)
3.0 BIOEFFICACY
3.1 Pests Controlled and Names of R R R R

Crops Materials as Premises to be
Protected
3.2 Application Rate (Kg ai/Ha or % ai R R R R
dilution rate)
3.3 Frequency and Timing of R R R R
Application for each site/pest listed
3.4 Method of Application R R R R
3.5 Phytotoxicity R R X X
3.6 Laboratory Studies if any X R X R
3.7 Effects on Beneficial Organisms X R X X
4.0 TOXICOLOGY
4.1 Acute Oral Toxicity R X R X

4.2 Acute Dermal Toxicity R R R R
4.3 Primary Eye Irritation R R R R
4.4 Primary Dermal Irritation R R R R
4.5 Studies to Detect Gene Mutation R X R X
4.6 Cellular Immune Response Studies R R X X
4.7 Intravenous, Intracerebral, X R X R
Interperitoneal Infectivity
4.8 Tissue Culture with Viral Agents X R X X
5.0 RESIDUE DATA
If rate of application exceeds 120 g R X X X

ai/Ha and if Tier I toxicological R X X
studies potential human hazard
106
Types of Data Food Crop Use Non-Food Crop Use

Biochemical Microbial Biochemical Microbial
6.0 NON-TARGET ORGANISM

TOXICOLOGY
Test developed in Tier I studies R R R R

EXPRESSION DATA
Tier I studies only R R X X
8.0 LABELLING
8.1 Proposed Toxicity Category R R R R

8.2 Draft Label (3 copies) R R R R
107
Table 8. METHODS OF DETECTING EFFECTS OF MICROBIAL PEST
CONTROL AGENTS IN SAFETY TESTS1
Method of Cellular Agents Acellular Agent Virus

Assessment Microbial Toxins (Bacteria, Fungi,
Protozoa)
Histopathology D X X
Serology2 NA D X
Nucleic Acid NA NA D
Hybridization3
Key to Table Symbols :
D : All members of this group detectable by this method.

X : Not all infections by this group are detectable by this method.
NA : Not applicable
1
Source: C.Y. Kawanisi, 1979
2
Radioimmunoassay, Enzyme-Linked Immunosorbent Assay
3
DNA: DNA and RNA: DNA Hybridization Techniques
108
Chapter 4
LICENSING, CERTIFICATION AND

ACCREDITATION OF PESTICIDE HANDLERS
109
4.1 LEGAL BASIS
Pursuant to Section 9 of PD 1144 and Sections 1 and 2 of Article III of the

FPA Rules and Regulations No. 1, Series 1977, all pesticide handlers must
obtain a license from the Fertilizer and Pesticide Authority.
“No person shall engage in the business of importing,

manufacturing, formulating, exporting, repacking, distributing,
storing or selling any pesticide, except under a license issued by
the Authority. A separate license shall be required for each
establishment or place of business subject to these rules, to be
conspicuously displayed therein.
All commercial applicators of pesticides shall apply for a license,

in a form to be supplied by the Authority and shall obtain a
commercial applicator’s license and be assigned a license number
by the Authority before such person shall perform services as a
commercial applicator. Each commercial applicator shall obtain a
license for each place of business maintained in the Philippines.”
4.2 APPLICATION AND REQUIREMENTS
4.2.1 Licensing of Pesticide Companies and Other Handlers
The licensing requirements and application forms for pesticide

companies and other handlers are as follows:
1. Application for Pesticide Manufacturer/Formulator License (Form

No. P-110).
2. Application for Pesticide Repacker License (Form No. P-120).

The applicator shall submit a written authority to repack from the
supplier.
3. Application for Pesticide Importer/Trader/Indentor License (Form

No. P-150). The license to import/indent is a pre-requisite to
opening a letter of credit. End-users are also required to obtain a
license to import.
4. Application for Pesticide Distributor License (Form No. P-160).

The distributor must submit a distributorship agreement with the
Pesticide Company and “Good Housekeeping Compliance
Certificate” issued by CRAN (CPAP Regional Action Network) and
FPA representative(s).
5. Application for Pesticide Supplier’s Local Representative/Local

Subsidiaries (Form No. P-170).
6. Application for Pesticide Dealership License (Form No. P-130).
110
7. Application for Pest Control Operator’s License (Exterminator or
Fumigator-Form No. P-180).
In addition, the applicant must submit the name and FPA

identification card number of the Certified Pesticide Applicator.
8. Application for Warehouse Registration (Form No. P-140).
Two copies of notarized application forms must be submitted

together with:
a. Copy of latest income tax returns;

b. Copy of latest financial statements; and
c. Copy of SEC registration (for new applicants).
These guidelines shall apply to agricultural and household

pesticide handlers. Handlers of both “agricultural” and “household”
pesticides are required to register under both classifications.
The prescribed application forms are attached as Annex VII.
4.2.2 Licensing of Dealers
Any person/partnership/corporation or cooperative desiring to sell

pesticides and other agricultural chemicals has to apply and secure a
license from the Fertilizer and Pesticide Authority (FPA), through the FPA
Provincial Officer.
In addition to the requirements stated under Section 4.2.1 for

pesticide companies, applications for dealership license must include:
1. Recommendation from the FPA Project Development Officer;
2. Copy of registration of business name with:
• Bureau of Domestic Trade for Single Proprietorship;

• Securities and Exchange Commission (SEC) for
Corporation/Partnership; or
• Cooperative Development Authority (CDA) for Cooperative;
3. List of pesticide companies/distributors represented and trade names

of products sold;
4. Copy of certificate of attendance to a half-day training on Pesticide

Safety for dealers intending to sell household pesticides for consumer
use and wood preservatives (except Termiticides, Inorganic
Arsenicals and PCB);
111
5. Copy of certificate of attendance to an Agro-Pesticide Dealers
Training and copy of report of rating for dealers intending to sell
agricultural pesticide products under Toxicity Categories III and IV
only;
6. Copy of certificate as Accredited Professional Pesticide Adviser

(APPA) for dealers intending to carry/sell pesticide products under
Toxicity category I to IV; and
7. “Good Housekeeping Compliance Certificate” issued annually by

CRAN and FPA representative(s).
For renewal, only requirement numbers 1, 3 and 6 above are

needed in addition to the requirements stated under Section 4.2.1.
A separate application form and corresponding fee shall be paid

for each branch and outlet.
4.3 VALIDITY, RENEWAL AND FEE
Licenses of “all handlers other than dealers” shall expire after one (1)
year from date of issuance. Dealership license shall expire three (3) years from
date of issuance thereof.
Renewal of licenses shall be filed at least three (3) months before its
expiry date. Application for renewal filed within one (1) month after the expiry
date shall be subject to a 50% surcharge while those filed after the said period
shall be subject to a 100% surcharge.
Fees and charges are computed on per activity basis. Fees and charges
for application and renewal of license of pesticide handlers are indicated in Table
9.
4.4 “GOOD HOUSEKEEPING” REQUIREMENT FOR LICENSING OF PESTICIDE

DEALERS AND DISTRIBUTORS
All licensed Pesticide dealers and distributors, including new applicants,

are required to meet the minimum standards of “Good Housekeeping” in the
storage and handling of pesticides both in the store and warehouse. The audit
team composed of CRAN member(s) and FPA representative(s) will issue a
proof of compliance in the form of a “Good Housekeeping Compliance
Certificate”. The establishment shall be inspected at least once a year and be
issued with the certificate of the minimum standards of “Good Housekeeping”
were met. A risk appraisal checklist for warehouse/store, Annex VIII, shall be
used during inspection. Those who fail to meet the minimum standards shall be
notified, and given a period of time within which improvements shall be made.
112
Integral to good housekeeping is the presence of appropriate
tools/gadgets to contain spillage of toxic materials and maintain cleanliness and
orderliness.
4.5 CERTIFICATION AND ACCREDITATION
The certification and accreditation program for pesticide handlers is

designed to update and upgrade the technical knowledge of commercial users,
distributors and dealers, researchers, and personnel of pesticide laboratories in
line with the standards and/or protocols set by the FPA.
4.5.1 Certified Pesticide Applicators (CPA)
A. General Information
Certified Pesticide Applicators (CPA) are those who have

attended a four-day training course and passed an examination
administered by the FPA. The training course and examination
are based on activity modules for exterminators and/or fumigators.
Corresponding identification cards are issued as a proof of
certification.
Accreditation simply gives the CPA the right to apply

restricted pesticides but not to purchase and enter into
commercial contracts for pest control work.
Establishments allowed to enter into contracts for the

commercial application of pesticides for extermination and/or
fumigation work are the Pest Control Operators (PCO).
Pest Control Operators are required to employ at least

one (1) CPA in the main office and one (1) in every branch
office as a requirement for the issuance of their business
licenses by the FPA. PCO’s who wish to do application jobs in
another region or province shall inform the FPA Project
Development Officer of such operations or activities.
B. Area of Coverage
Certified Pesticide Applicator may be pest exterminator

and/or fumigator depending on the activity of the Pest Control
Operator he is working with.
The areas of activity coverage include, but not limited to,

the following:
113
1. Homes, hotels, townhomes and subdivisions.
2. Buildings such as schools, hospitals, food factories and

other food handling establishments, commercial buildings
and those under construction, movie houses and
bodegas/warehouses.
3. Transportation facilities such as air, land and sea transport

for public and private use.
4. Handicraft factories and container van with export

materials.
5. Lumber yards and other treatment processing plants.
6. Other facilities engaged in the protection of stored,

processed or manufactured products.
C. Application Requirements and Certification of Pesticide Applicator
Applicant to the program must accomplish the appropriate

FPA forms and together with the other required documents,
submit them to the FPA. These documents will be evaluated and
applicant will be notified accordingly.
The applicant must possess the following qualifications:
1. A Filipino citizen;
2. Of legal age; and
3. Have a college level education.
Only applicants who have attended the training course

shall be allowed to take the FPA examination. Exemption from
attending the course shall be based on the merit of the case.
Applicants who have passed the examination with a

minimum grade point average of 70% will be certified and issued
identification card.
Those who obtained a rating of 66-69.4% may take a

removal examination on schedule set/announced by FPA without
undergoing another training course. Removal examination shall
be taken only once and within one (1) year from date of issuance
of the report of rating.
114
D. Responsibilities of CPA
The CPA must demonstrate competence and practical

knowledge in the safe use, handling, storage and disposal of
restricted pesticides, the life cycle of a wide variety of pests, types
of formulations appropriate for pest extermination and fumigation
and of the safe and effective pest control practices as well as the
appropriate protective clothing
He must have direct supervision of service technicians and

must always be present during the application of the restricted
pesticides. He must keep a record of the name and address of
clients, chemical, pesticide formulation and amount used and the
target pests most especially when restricted pesticides are used.
All these records must be made available to FPA every six (6)
months.
He must regularly attend symposia or seminars sponsored

by the Pest Control Association of the Philippines (PCAP),
Philippines Association of Professional Fumigators, Incorporated
(PAPFI) and other professional organizations. He must inform
FPA of the termination of his services with the PCO registered
with the FPA and/or his movement to another pest control
company.
E. Validity, Renewal and Fee
Identification card is issued only to CPA employed in a

Pest Control Company/Institution. It has a validity period of one
year. Pre-requisite to renewal is attendance to one symposium
and payment of the corresponding fee (Table 9).
4.5.2 Accreditation of Professional Pesticide Adviser (APPA)
Pesticide formulations belonging to Categories I and II

under the FPA Toxicity and Hazard Classification scheme are
undergoing review for policy action. Aware of the long and
tedious process involved, FPA instituted the Accreditation of
Professional Pesticide Adviser (APPA) who must be at the store to
advise buyers on the safe use of pesticide formulations belonging
to the aforementioned categories.
Henceforth, all FPA licensed dealers/outlets wishing to

carry or sell all four (4) categories of pesticide products must
employ at least one Accredited Professional Pesticide Adviser
(APPA). FPA licensed dealers/outlets without an APPA are
115
allowed to carry or sell only pesticides belonging to Categories III
and IV only.
Pesticides under Categories I and II shall not be sold in the

absence of an APPA.
B. Procedure and Requirements
Applicant must be a graduate of a four (4) year college

course or a two (2) year diploma course in agriculture. He must
undergo an APPA training conducted by the FPA in coordination
with the Weed Science Society of the Philippines (WSSP) or other
professional societies: pass the written examination and take an
oath of responsibility administered for such purpose before an
accreditation card is issued to him/her.
The passing mark for APPA examination is set at 70%.

Those who obtained a rating of 60-69% may take removal
examination on schedules set/announced by FPA without
be taken only once within the year from the date of issuance of the
report of rating.
Accreditation on a testimonial mode may be given to an

owner/dealer of an FPA licensed agricultural supply store who is
either a graduate of a four (4) year course in agriculture or a
retiree, who has been in that business for at least ten (10) years
provided he/she has attended the prescribed training. The
requirement of taking or passing the examination is waived.
Accreditation card will be issued upon compliance with the
requirements.
C. Responsibilities of an APPA
The APPA must be personally present in the store to give

advice to clients on the safe use of pesticides during its actual
sale. No sale or transaction shall be conducted to customers of
pesticide products falling under Category I and II when APPA is
absent. He must keep records of sale/disposition of Category I
and II products which must be available for inspection by FPA
authorized personnel. If employed by a licensed dealer, he must
inform the FPA of the termination of his services and/or transfer to
a new employer for issuance of a new accreditation card reflecting
his new employer.
D. Validity, Renewal and Fee
The accreditation with validity for three (3) years is

renewable simultaneously with the renewal of dealership license.
Failure to renew will automatically place the APPA into the
116
inactive status which can be reverted to the active status upon
renewal and payment of the prescribed fee (Table 9).
4.5.3 Accredited Responsible Care Officer (ARCO), Master Instructor -

Responsible Care Officer (MI-RCO) and Responsible Care Officer
(RCO)
The Responsible Care Program of the FPA aims to

professionalize the role of handlers of crop protection products
who are directly or indirectly involved in food production. In this
undertaking, highly qualified people are tapped to provide
excellent leadership and management practices in protecting the
people, especially the farmers and our environment from the
adverse effects which may result from handling of crop protection
products. The paramount goals are to minimize injuries, prevent
adverse environmental and health impacts, manage waste,
pollution and emission to acceptable low levels and to conserve
resources. To achieve these goals, FPA/Company Responsible
Care Officers/Accredited Responsible Care Officers must be
fielded in all regions and provinces where the companies operate.
Recognizing the role of the Industry in pursuing product

stewardship programs, FPA coordinates with the Pest
Management Council of the Philippines (PMCP) Foundation or
other professional organizations to work out a sustainable scheme
towards continuous efforts in educating pesticide handlers,
particularly farmers, in the judicious and safe handling of crop
protection products.
The MI-RCO, RCO, ARCO training courses cover a wide

range of subject matters on pesticides and tools for effective
communication. Specifically, the courses cover pesticide
regulations, general information on pesticides, research and
development on pesticides, pesticide packaging materials, safety
in formulation plants, pesticide handling, education and training,
monitoring and auditing concepts and procedures, environmental
issues, and pest clinic which includes, plant disease, weed and
insect recognition and management. The courses include lectures
and a workshop on how to become an effective trainor.
Performance is evaluated through a written examination

administered by FPA at the end of each course.
117
B. Coverage and Requirements
All handlers, other than dealers and PCOs, duly licensed

by FPA are required to employ at least one ARCO. This
requirement also covers new applicants for a handler’s license
and all FPA full-time and deputized Regional and Provincial
Development Officers.
The Master Instructor-Responsible Care Officer (MI-RCO)

must attend the two-day Master Instructor Course but need not
take the examination.
The Responsible Care Officer (RCO) must attend the four-

day training course and pass the written examination administered
for the purpose. They are currently employed as field personnel
of pesticide companies or field officers of FPA.
The Accredited Responsible Care Officers (ARCO) must

attend the four-day training course, pass the written examination
and be issued an accreditation card. They may be proprietors or
employees of the above-mentioned licensed pesticide handlers.
The passing mark for ARCO/RCO examination is set at

70%. Those who obtained a rating of 60-69% may take removal
examination on schedules set/announced by FPA without
be taken only once and within one (1) year from the date of
issuance of the report of rating.
New issuance and/or renewal of license of the above-

mentioned handlers will require the employment of at least one (1)
ARCO. This requirement is for each type of license issued.
C. Responsibilities of MI-RCO, RCO and ARCO
The MI-RCOs shall, in addition to their stewardship

responsibilities in their respective companies, be tapped as
trainors during the scheduled trainings for RCOs/ARCOs at
various areas in the country.
The RCOs/ARCOs shall, at the end of their

training/accreditation, be expected to initiate the promotion of
responsible care program in their respective companies.
The MI-RCO, RCO and ARCO shall provide active

leadership in the education and training of farmers, contracted
applicators and other relevant clientele.
118
Accreditation for ARCO will be valid for a period of three

(3) years. Each renewal thereafter will require payment of fee
(Table 9.) and submission of accomplished application form and
proof of attendance to at least two (2) symposia jointly planned
and executed by FPA, Crop Protection Association of the
Philippines (CPAP) and other professional organizations/societies.
4.5.4 Accredited Pesticide Dispenser (APD)
In the absence of an APPA, an Accredited Pesticide Dispenser

(APD) shall be required for all licensed dealers selling pesticides
belonging to Categories III and IV. The APD may be the owner or
salesperson who has attended a two-day training for agro-dealers and
passed the written examination. The accreditation, with a validity of three
(3) years is renewable simultaneously with the renewal of the dealership
license.
Application for accreditation may be filed at the FPA regional or

provincial office by submitting duly accomplished information sheet, two
(2) 1” x 1” ID pictures, photocopy of certificates of attendance to the
training and report of the examination rating.
See Table 9 for appropriate application fee.
4.5.5 Accreditation of Researchers
Researchers who conduct experiments to generate

biological efficacy data for a product in support of registration are
required to attend a two-day training workshop for accreditation.
The research disciplines include Entomology, Plant Pathology,
Weed Science, Nematology, Statistics, Pesticide Toxicology and
Analytical Chemistry, Rodent Control, Plant Physiology, Plant
Nutrition Malacology and other allied research disciplines.
The training workshop is designed to introduce the FAO

research protocols for the different disciplines on testing
pesticides and the FPA protocols on testing fertilizers. It also
reviews statistical design for experimentation and writing the
research terminal report. The workshop output includes
presentation of test protocols for representative disciplines and
crops written by the participants and critiquing of the protocols.
119
B. Procedure
The applicants are required to submit a filled-up application

for accreditation of researchers (Form No. P-300) together with a
copy of his biodata.
The applicant must apply for accreditation on the discipline

well supported by his academic specialization, training, published
research or current research undertakings, and years of research
experience to indicate competence.
Expansion of accreditation for additional research

discipline may be granted upon request provided that it is
supported with authorship of one (1) publication in a refereed
journal or two publications in non-refereed journals along the
research discipline being applied for.
C. Guidelines for FPA-Accredited Researchers
1. Researchers should only conduct experiments on pesticides or

fertilizer covered with Experimental Use Permit if the data will
be used for the registration of the product.
2. Researchers should carry out only experiments within the limit

of their accreditation.
3. Researchers are required to self regulate the total number of

experiments conducted. In cases where more than five (5)
product or crop trials are to be handled at one (1) time, prior
approval from FPA is necessary.
4. In cases where government facilities will be used and the

researchers are employed by the government, prior approval
from the head of the concerned agency is required before
starting the research.
5. Researchers employed by chemical companies are not

allowed to conduct product efficacy trials intended for
registration. Their role is limited to the supervision of the trials
conducted by other contracted accredited researchers.
6. A certificate signed by the researchers indicating that the study

was conducted following good agricultural practices and
standard protocol.
120
The accreditation card issued to a researcher upon

payment of the required fee is valid for two (2) years. Failure to
renew the accreditation would automatically classify the
researcher to inactive status.
Separate fees are required for the first and the additional
activities or disciplines (Table 9).
4.5.6 Accreditation of Pesticide Formulation and Residue Laboratory(ies)
FPA shall tap only FPA Accredited Laboratories in monitoring

pesticide residues in agricultural commodities and the environment and in
the regulation of pesticide formulations. It is through the process of
accreditation that FPA can ensure reliability of pesticide monitoring data
from participating laboratories.
The accreditation covers only the technical competence of the

laboratory(ies) to assure accuracy of analysis and results. It is assumed
that the laboratory(ies) take(s) responsibility for quality system as
prescribed by ISO Guide 25.
A. Area of Coverage and Requirements
Accreditation involves sound evaluation of the following areas:
1. Basic Resources
a. Equipment. The laboratory should be equipped with

properly maintained and adequately calibrated
equipment appropriate for sampling, storage, sample
preparation, extraction, clean up, actual determination
and calculation using basic data handling apparatus.
Equipment for residue determination are grouped
according to sophistication (i.e. GC-MS, GLC, HPLC,
etc.)
b. Facilities and Utilities. Facilities include air-

conditioning, waste disposal system, exhaustion,
safety, and first-aid as well as adequate supply of
power, water and gases.
2. Manpower - Manpower requirement is based on the

educational attainment, training, experience and personal
accountability.
a. Analyst - The analyst must be a B.S. Chemistry

graduate or a graduate of any science course who has
121
taken at least 15 units of chemistry and with at least
one (1) year experience in chemical analysis. During
actual analysis, the non-chemist should be under the
supervision of a pesticide chemist.
b. Certifying Chemist and Alternate - Certification of

results must be made by a registered chemist with
experience in pesticide residue analysis. He or she
must have at least one (1) year rigid training specific to
pesticide residue analysis subject to the evaluation of
the accrediting body.
c. Issuing Authority and His Alternate - Only two (2)

names are authorized to issue the results which should
be submitted and approved by the accrediting body.
3. Methodology
a. Test Methods. The test method prescribed and

authorized by the Codex Committee on Pesticide
Residues (CCPR) and CIPAC must be adopted. If
there is any modification of the test method, this
should be properly documented and validated.
Validation should be done with certified material or
by running two (2) parallel methods (one,
conventionally accepted; the other, being the
modification).
b. Proficiency. The test method must be properly

documented and method calibration should be
adequate. The laboratory should conduct test
proficiency using standard reference material
(SRM) provided by FPA. For the following year, the
laboratory should join the inter-laboratory test
comparisons prescribed by the accrediting body.
B. Procedure
Heads of pesticide residue and formulation laboratories,

usually referring to persons needing to be accredited, should write
FPA of their desire and provide information on their capability. An
assessment team composed of three (3) members will be
scheduled to inspect the facilities and interview their staff.
Evaluation report and recommendation of the team will be
submitted and discussed with FPA management. Applicants will
be notified of the result within fifteen (15) days.
Applicants who have passed the standards set by FPA will

be issued a certificate of laboratory accreditation.
122
C. Validity, Renewal and Fee
The Certificate of Laboratory Accreditation is valid for two

(2) years. Renewal is subject to further inspection and the report
and recommendation of the assessment team.
The applicant is charged with the actual cost during

inspection by the evaluation team. See Table 9. for the prescribed
fee.
4.5.7 Procedure for Revocation of Accreditation, Certification and

Licenses
All types of accreditation, certification and licenses may be

revoked or suspended by the FPA on the basis of the following:
1. False statements in the documents submitted to the FPA or any

acts of dishonesty, fraud or deceit.
2. Violation of PD 1144 or failure to observe FPA Rules and

Regulations.
3. Ignorance, negligence, poisoning or death in the community by his

direct action or through persons under his supervision.
4. Application, or supervision of the use, of any restricted pesticide in

a manner inconsistent with its labelling.
5. Non-compliance with the required use of safety equipment and/or

operation of faulty or unsafe equipment causing injury or death of
the applicator.
6. Refusal to allow inspection of premises and records or to give

information requested by FPA.
The licensee will be notified of the revocation/

suspension/cancellation of his accreditation, certification or license
through registered mail. Opportunity for a hearing before the FPA must
be requested formally within ten (10) days after receipt of notice. Punitive
action is enforced until the final outcome of the hearing.
For accredited researchers, first offense will be dealt with a written

reprimand. Succeeding violations will be dealt with in the same way as
the PCO or CPA.
123
Table 9. SCHEDULE OF REVISED FEES AND CHARGES FOR
ACCREDITATION/LICENSING OF PESTICIDE HANDLERS *

(in Pesos)
I. LICENSING OF FERTILIZER AND PESTICIDES HANDLERS,

FERTILIZERS & PESTICIDE DEALERS & WAREHOUSES
A. Fertilizer and Pesticide Handlers other than Dealers

(annually)
Over P 5M capitalization
1st activity 8,500.00
Additional activities 5,000.00
P 1M to 5M capitalization
P 500T to 1M capitalization
P 500T & below capitalization
Addt’l activities 1,000.00
Filling fee/activity for new applications
Manufacturer 7,500.00
Formulator, repacker 7,500.00
Institutional Users 7,500.00
Other activities 2,000.00
B. Pest Control Operations (Annually) 1,200.00

Members of PCO associations
C. Accreditation Fee for Certified Pesticide Applicator 600.00

(Annually)
D. Accreditation of Researcher (Annually) 600.00

Additional disciplines 200.00 each
E. Accreditation fee for Accredited Responsible Care Officer 300.00

(Annually)
F. Accreditation of Laboratories 10,000.00
*
Subject to change
124

(in Pesos)
G. Mango Contractors (Annually) 1,200.00

Members of accredited associations 600.00
H. Dealers (renewable every 3 years)

Pesticide Dealers 2,500.00
Members of dealer’s associations 2,000.00
mall hardware stores (with option to pay annually or every 1,800.00 /3 yrs.
3 years)
mall outlet retailing Household pesticide with annual sales 450.00 /3 yrs.
of less than P 50,000.00 (renewable every 3 years)
Dealers of both Fertilizer and Pesticide 4,000.00
Members of dealer’s associations 3,200.00
Cooperatives 50 % of dealers fee
I. Accredited Pesticide Dispenser 360.00 /3 yrs.
J. Accredited Professional Pesticide Adviser (Annually) 300.00
K. Warehouses (Annually)
Pesticide 2,000.00
Both Fertilizer and Pesticide 2,400.00
II. PROCESSING FEES
CAIP Issuance
a. General Use 750.00
b. Red Labelled & Restricted Use 3,000.00
Amendment Certification 750.00
Export Permit 1,500.00
Permit to Purchase Restricted Pesticide 450.00
III. ALL OTHER CERTIFICATIONS 350.00
125
Chapter 5
PRODUCT STEWARDSHIP AND

RESPONSIBLE CARE
126
There is a great possibility that the majority of pesticide users might have
been unduly exposed to pesticides during and after application due to inadequate
appreciation and understanding of the hazards involved. In this regard and in the
interest of the common good, the principle of pesticide company product
stewardship has been adopted as a means of addressing the hazards and risks
to human health and the environment associated with the use of pesticides.
Pesticide companies shall exercise product stewardship to ensure that their
products are properly handled and safely used. It covers the entire cycle from
the introduction, manufacture, formulation, marketing, application to the use of
the products including proper waste disposal.
The FPA recognized the fact that the Crop Protection Association of the
Philippines (CPAP) and similar organizations have already adopted in their Code
of Ethics the Product Stewardship Principle and this paved the way for the
formulation and issuance of the following guidelines on product stewardship.
5.1.1 Policy Guidelines on Product Stewardship
1. The Company concerned shall ensure that its products are

handled properly and workers protected during formulation,
storage, transit, application and disposal. The Company
concerned must submit a report covering the manufacturing or
formulation process, the volume and quantity of products
(imported, processed, marketed and sold), the number of workers
involved, safety precautions employed, waste management and
disposal methods, including the residue levels in the wastes
emitted/ disposed, etc.
2. The Company concerned shall provide the necessary training on

the safe handling and use of its product (including proper waste
disposal) to dealers and users following FPA approved modules.
A yearly report which includes annual training schedules shall be
submitted to FPA.
3. The Company concerned shall provide, at cost, protective clothing

such as aprons, gloves, masks and boots to users of its product
especially those belonging to Categories I and II pesticides. The
company shall ensure the continued supply of these protective
clothing and equipment for as long as its products belonging to
Categories I or II are marketed.
4. The dealers concerned shall make available first aid kits while the
company shall provide antidotes for its product to the nearest
medical facilities as determined by FPA. The provision of
antidotes to medical facilities shall be made annually and reported
to FPA.
127
5. All companies concerned shall provide information services to the
public. The nature and scope of these services shall be subject to
FPA approval.
6. The Company concerned is obliged to report to FPA any

information adversely affecting the safe use of its product within
the quarter that such information has become known.
7. The Company concerned shall stop the sale of and recall its
product which has been found or deemed unsafe for use under
any use directions or restrictions by FPA. The Company
concerned must shoulder all the expenses that might be incurred
in the retrieval and proper disposal of the recalled products.
5.1.2 Performance Review
There shall be periodic review, at least once a year, of the

stewardship activity and performance of the pesticide company.
5.1.3 Penalty for Violations
Any violations of the provisions of the preceding policy guidelines

on product stewardship, including the clause performance review, shall
be subject to punitive action in the form of fines, sanctions, suspensions,
cancellations or revocation of registration permit and/or company license.
Any Company cited for violation shall be given due process but the FPA
reserves the right to impose the degree of penalty based on the
provisions of PD 1144 and FPA rules and regulations.
5.2 RESTRICTIONS ON AVAILABILITY AND USE
Because of their inherently toxic nature, not all pesticides can be

allowed for use by the general public. Some pesticides need to be
restricted to avoid undue risk to the applicator and the general public or
the environment. Generally, restriction is to a particular class of user,
such as a certified applicator or an institutional user.
A. Legal Basis
According to Section 6, III (3) of PD 1144, FPA is vested

with the following powers and functions:
“ To restrict or ban the use of any pesticide or the

formulation of certain pesticides in specific areas or
during certain periods upon evidence that the
128
pesticide is an imminent hazard, has caused, or
causing widespread serious damage to crops, fish
or livestock, or to public health and the
environment.”
Further, Section 5 Art. II (c) of the FPA Rules and

Regulations No. 1; Series of 1977, provides:
“If the Administrator determines that the pesticide,

when applied in accordance with its directions for
use, warnings, and cautions and for the uses for
which it is registered, or for one or more of such
uses, or in accordance with a widespread and
commonly recognized practice, may generally
cause without additional regulatory restrictions,
unreasonable adverse effects on the environment,
including injury to the applicator, he shall classify
the pesticide, or the particular use or uses to which
the determination applies, for restricted use;
2. ...the pesticide shall be applied only or under

the direct supervision of a certified applicator.
3. ... the pesticide shall be applied for any use to

which the determination applies only by or
under the direct supervision of a certified
applicator, or subject to such other restrictions
as the Administrator may provide by regulation.”
5.2.2 Basis for Restrictions
Restrictions on availability are based on assessment of hazards

due to the toxicity of pesticides, exposure potential and phytotoxicity to
crops. Adverse effects and risks involved in the use of a particular
product shall be carefully weighed against the benefits. Each compound
shall be considered on its own merits. Use patterns and the presence of
“equivalent” compounds which are less hazardous for the same uses
shall also be taken into consideration.
In toxicology, reliance on a single toxicological criterion especially

acute toxicity is not advisable. A compound cannot be restricted solely
because of high oral toxicity. Oral toxicity is more of a suicide or
inadvertent intake problem. Other toxicological parameters as well as the
physical and chemical properties of a compound shall also be considered.
129
5.2.3 Restriction Categories
For the purposes of FPA, four restriction categories have been

adopted: (1) Banned pesticides; (2) Restrictions because of hazard; (3)
Restriction of purposes of gathering more information; and (4) Restriction
due to possible crop phytotoxicity in an ordinary farmer’s cultural practice.
A. Banned Pesticides
Banned pesticides are those which cannot be brought into

and used in the country under any circumstances. Included in this
classification are pesticides which have been found unacceptable
for use under normal situations whose registration have been
cancelled by FPA or voluntarily withdrawn by the concerned
company. Pesticides banned in other countries may be allowed to
be brought into the country under the Principle of Prior Informed
Consent (PIC).
B. Restriction Due to Health Hazards
It must be clearly understood that any pesticide under this

category shall not be allowed under any circumstances or
likelihood to be released for general use.
The following factors are considered in making this

determination:
1. Acute, chronic and subchronic toxicity in relation to

formulation and use patterns;
2. The absence of antidotes in cases of poisoning;
3. Suspected carcinogenecity, mutagenicity or teratogenecity;

and
4. Environmental properties, e.g., long residual life, high

bioaccumulation potential and high leachability in soil.
C. Restriction to Gather More Information
Compounds in this category are believed to have some

potential adverse effects which shall be monitored under
Philippine conditions. This category is used to obtain additional
local experience and some benefits prior to general sale while
under closely controlled conditions.
D. Restriction due to Phytotoxicity to Crops
This restriction is most applicable to herbicides. There are

instances when the tolerance of a crop to a particular herbicide is
130
dependent upon certain conditions which may not be followed
under ordinary farmer’s field conditions. Perfection of the
technology together with farmer education may be requisites for
general use.
5.2.4 Pesticides For Institutional Use Only
One of the restricted categories adopted by the Philippines is the

limitation of the use of the pesticide to institutions only. While the
adoption of this category of restriction is, in general, in accordance with
international practice, the guidelines have been modified to be responsive
to the specific situations in the country.
An institutional user differs from ordinary farmer with respect to

being able to exercise close supervision of pesticide application during all
phases of the activity. This means that occupational exposure can be
limited to smaller and more homogeneous groups. Prohibitions and
protective clothing requirements, exposure times and other factors in
applicator safety can be more readily managed. Simple expediency of
limiting exposure time of workers to nil-exposure situations may prevent
some effects. There is a higher awareness level in institutional users
than farmers, in general. It is also easier for FPA to reach, or even
monitor, a large group of users through an arrangement with institutions.
Pesticide for institutional use only shall be made available directly

from the Philippine distributor/importer to the institution solely and directly.
There will be no over-the-counter sales through the regular dealership
networks.
It is stressed that restrictions to institutional users may be made

only if FPA is convinced that some advantage can be gained by such
action, e.g., the compound is useful but has some demonstrated or
potential adverse effects that make general use inadvisable. However,
general prohibition of use in the country would be disservice to Philippine
agriculture. If sufficient information is generated, and if upon examination
of submitted evidence FPA warrants such action, the restrictions may be
removed.
FPA Requirements for Restrictions for Institutional Use Only
The following requirements shall be met if a pesticide product has

been restricted to institutional use only:
1. Access to a medical facility having capabilities to deal with poisoning

or other potential adverse effects must be available;
2. Strict compliance with FPA requirements for protective clothing, safety

devices, exposure limits and other safety precautions established for
use of the compounds;
131
3. File periodic reports to FPA on the observed or lack of observed
adverse effects;
4. A report on the disposition of all stocks must be submitted to FPA by

the registrant;
5. In the case of “Restriction to Gather More Information”, a complete

summary report on the areas with incomplete data shall be filed by the
registrant at the end of the probation period;
6. “For Restriction Due to Phytotoxicity”, a summary report on advances

in technology, training and evidence of phytotoxicity under restricted
use shall be submitted to FPA by the registrant at the end of the
probationary period; and
7. Other requirements deemed necessary for the particular pesticide and

use conditions.
5.2.5 Use of Pilot Areas
In some cases, FPA may permit the use of pilot areas in lieu of
institutions. This is particularly true for restrictions designed to gather
more information and improve pesticide selectivity. This option may be
exercised if FPA assesses that the pesticide is only of limited use to
institutions so that the spirit and intent of the restriction cannot be fulfilled.
In the case of gathering more information, the following shall be
observed/required:
1. A demonstration by the registrant that proper medical facilities are

available in the pilot area;
2. An extensive information campaign must be conducted in the area

appraising users of the potential hazard of the pesticide and
requiring them to immediately report any adverse effects to the
medical facility staff;
3. An adequate monitoring and reporting system must be

implemented with periodic reports submitted to FPA;
4. The registrant shall bind himself to compensate users for any

adverse effects suffered from the pesticide in an amount to be
determined by FPA; and
5. The registrant shall submit a summary and complete report on the

adverse effects, technology improvement and training at the end
of the observation period.
132
5.2.6 Pesticides for Certified Pesticide Applicator Use Only
PD 1144 provides that restricted pesticides should be used and

applied only by and under the direct supervision of certified pesticide
applicators, or under such conditions as the FPA may require.
Some pesticides need to be used throughout the country but can

cause problems if misused. One predominant class is comprised of those
pesticides used in and around the home to control termites. These
compounds are highly toxic and persistent, but the untrained user can
misuse them and may contaminate the environment with severe
economic consequences or health problems.
For these reasons, such pesticides are restricted, for use solely by
Certified Pesticide Applicators (CPAs). Distribution of such materials and
their advertising shall also be controlled.
5.2.7 List of Banned and Restricted Pesticides
FPA shall publish from time to time a list of banned and restricted
products to provide guidance to pesticide users and the public. The latest
listing is included in this guide book as Annex IX. Since this can and will
change on a short notice during the course of the registration process,
interested parties should contact FPA for the most current information
about a specific pesticide and its use. Attached, as Annex X are
additional circulars on restrictions of specific pesticide products.
5.3 FORMULATION AND PACKING
5.3.1 Introduction
Formulation and packing are among the important processes in

the production and distribution of pesticides that ensure the quality and
stability of the product. This section describes the standard and
requirements for the safe manufacture of pesticides particularly with
regard to formulation and packing, as well as the health/safety and
environmental aspects.
A. Common Types of Formulation
The three (3) common types of formulation are as follows:
1. Liquid Formulation - all materials are pre-weighed, and

then charged into the mixing tank. It is blended for a
certain period of time (approximately 30 min. or more) to
attain a homogenous mixture.
133
2. Powder Formulation - all materials are pre- weighed, and
then charged into a ribbon-type blender. It is then blended
for a certain period (approx. 20 min.) depending on the
batch size. If the specifications require that the product be
pulverized to finer particles, it undergoes a milling process.
3. Granular Formulation - the carriers are pre-weighed,

charged first into the mixer. The liquid technical materials
are then sprayed inside. The rest of the materials are
mixed to coat and dry the granules.
B. Common Equipment Used in Formulation
Any company engaged in the formulation of pesticides

shall have the following minimum set of equipment:
1. Liquid Formulation
• Weighing Scales
• Pneumatic Pumps
• Blending/Mixing Tanks
• Storage Tanks
• Sandmill (Optional)
• Cooling/Heating Equipment (Optional)
2. Wettable Powder Formulation
• Weighing Scales
• Ribbon Blenders
• Pulverizing Equipment (Optional)
• Dust Collector
• Bucket Elevators (Optional)
• Storage Bins/Hoppers
• Densifiers (Optional)
3. Granular Formulation
• Weighing Scales
• Munson Blender
• Bucket Elevators
• Storage Bins/Hoppers
• Extruder} for extruded
• Dryers } granules
C. Common Types of Packing
1. Liquid Packing - the process of placing the liquid formulated

materials into suitable containers, such as: glass bottles,
plastic bottles or jugs, tin cans, plastic or steel drums, etc.
134
2. Powder Packing - the process of placing the powder-
formulated materials into the suitable containers, such as:
polyethylene bags, polypropylene sacks, paperboard boxes,
fiber drums, etc.
3. Granular Packing - the process of placing the granular

formulated materials into suitable containers, such as:
polyethylene bags, paper bags, corrugated cartons, fiber
drums, etc.
5.3.2 Safety, Health and Environmental Aspects
A. Facilities
1. Ventilation
a. General Ventilation
The building shall be well ventilated

principally to provide agreeable working conditions.
Open-sided buildings (if site security is good) will
achieve this naturally.
Where there are walls, vents shall be placed

in the roof or in the wall just below roof level, as
well as near the floor. However, this system shall
not be used to remove toxic dusts or fumes. Local
exhaust (source) ventilation must be established for
this purpose.
b. Local Exhaust (Source) Ventilation
Local exhaust (source) ventilation is the

only effective way of stopping harmful dusts and
fumes from being released into the workplace. To
be effective, the intake to the ventilation system
shall be placed as close as possible to the source
of the contamination. All such sources shall be
enclosed as far as possible.
c. Room Ventilation
Room ventilation shall be used where

equipment cannot be ventilated locally because of
its size, shape or function. It is essential that the
source of contamination shall be between the
operator and point of extraction, and, that all other
openings to the room shall be reduced to a
minimum.
135
d. Emission Control
Where ventilation is used to control dust

sources, the discharged air must be filtered. In
exceptional cases, vapors and odors may require
specific treatment.
2. Lighting
The plant must be sufficiently lighted (natural or

artificial) to permit safe operation.
3. Electrical Equipment
All electrical equipment (including electrically-driven

forklift trucks) used in plants handling flammable materials
must be approved from a fire-safety viewpoint and must be
maintained to a safe standard. Permanent electrical
installations shall be used whenever possible; flexible
electrical leads, where used, shall be kept short.
B. Formulation and Filling Equipment
1. Liquids (Fire-explosion Precautions)
Many of the liquid pesticide formulations are based

on flammable organic solvents. In liquid formulations and
filling plants using such solvents, there is always the
possibility of an explosive mixture of air and vapor building
up. For this reason, all electrical equipment in the vicinity
of the formulation and filling units must not produce sparks
and must be approved from a fire and explosion viewpoint.
Naked flames and spark-producing tools and

accessories must not be used in such areas, except with
the special approval of the plant manager. This prohibition
includes petrol or gas motor-driven vehicles such as forklift
trucks.
To prevent build-up of static electricity, all equipment

must be adequately earthed, with earth-bonding straps or
cables being used where appropriate to maintain earth
continuity. Drums should also be earthed during emptying
and filling. Charge build-up through splashing should be
minimized by the use of dip-pipes in drums and vessels. A
particular risk exists when powders are being loaded into
vessels containing flammable liquids, especially from
conductive containers such as plastic bags. Loading
should be done slowly and, if possible, from an earthed
conducting container.
136
2. Solids (Fire/explosion Precautions)
If the PDS states that a solid product presents a

dust explosions hazard, equipment must be protected with
explosion-suppression, explosion-venting or inert-gas-
blanketing system and the recommended formulation and
mixing procedures must be strictly followed. Specialist’s
advice must be sought with respect to the adequacy of the
equipment.
All parts of the equipment must be earthed, using

earth-bonding straps where necessary to ensure earth
continuity. Conductive materials must not, under any
circumstance, be isolated from earth.
3. Industrial Hygiene Precautions
Exhaust ventilation with a minimum air velocity of

0.5 m/sec must be provided at the charging and
discharging points. Empty packaging material should be
carefully collected in a container to keep dust in the
working area to a minimum.
4. Filling and Packing Equipment
Packaging equipment for filling liquids and solids

shall be equipped with local exhaust (source) ventilation
with a minimum air velocity of 0.5 m/sec.
Liquid filling equipment shall be free of leaks. It

shall have a guard to prevent splashing on to operators,
and a collection container for drips and spills.
All filling machines shall automatically close when

de-energized.
Filling and packing machines shall have protective

guards to prevent fingers or clothing being caught.
C. Operational Procedures
1. General
a. Supervision and line of responsibility
Operations within the formulation and

packing plant shall be closely supervised by a
trained and experienced supervisor. If there are
several supervisors of different levels, the area and
line of responsibility shall be clearly defined and
understood.
137
b. Working instructions and procedures
The following written instructions and working

procedures shall be readily available to the
supervisor:
• Instructions for safe and correct operation of the

equipment
• Formulation recipe, blending and packing
procedures
• Product Data Sheets for ingredients and
finished products
• Hygiene and safety instructions and procedures
• Equipment cleaning procedures.
c. Training
All personnel working in the formulation and

packing plant shall be thoroughly trained at the
beginning of their employment. Thereafter, regular
training programs shall be held to prevent the
development of bad working practices.
A permanent record of the instruction received shall
be kept. Safety and hygiene practices shall be part
of the regular training program.
d. Constraints
Pesticides shall not be formulated or packed in

equipment in which products for human or animal
use, such as foodstuffs, cosmetics, etc., are also
formulated and packed.
If non-pesticide products, for example, brake fluids,

lubricants, etc., are blended and packed in the
same equipment as pesticides, precautions shall be
taken to prevent cross contamination.
2. Hygiene and Safety
Before formulating any pesticide or packing it, the

supervisor shall check that all necessary plant hygiene and
safety equipment, such as exhaust ventilation equipment
are operational. He must also ensure that operators are
wearing the necessary personal protective equipment. If
such equipment is being re-used, it must first be properly
cleaned and inspected.
138
The supervisor shall also ensure that the working
area is in a condition that permits safe working. For
example, it should not be crowded with containers and
unnecessary equipment.
Workers must avoid all contact with the products,

but in the event of accidental contact, they must remove
contaminated clothing immediately, wash the skin and treat
it according to the specific instructions given in the PDS.
3. Formulation and Filling Procedures
Strict precautions shall be taken to prevent cross-

contamination. For example, a fungicide contaminated
with an insecticide could present hazard to the user, and
an insecticide contaminated with a herbicide could cause
crop damage.
An effective system shall be adopted for identifying

the correct ingredients required by the recipe.
Strict procedures shall be laid down for dosing of

ingredients into formulating equipment in order to avoid
mistakes.
Accurate records shall be kept for the batch or lot

numbers and weights of all ingredients used in each
identifiable batch of formulated product.
Products shall be checked regularly for quality, and

a reference sample system be established to enable
investigation of possible complaints.
Because of the risk of operator contact, the filling

and packing of pesticides can be one of the most
hazardous operations in a pesticide formulation and
packing plant. Equipment shall be well maintained to
prevent leaks and drips. The supervisor shall ensure that
all safety devices are operational and that safe and
hygienic working procedures are being followed.
5.4. PACKAGING MATERIALS
This section describes the standards and requirements for packaging

materials.
5.4.1 Packaging Standards
139
A. Packaging Standard Line
Formulation Packaging size Packaging unit

Liquids: Small Bottles (PE, glass, AL)
Canisters (tin, PE)
Large Barrels (Iron-steel)
Powders: Small Bottom Bags (PE, paper, AL)
Tubular bags
Sacks
Large Sacks (PE, paper)
Drums (Iron-steel)
B. UN Performance Tests on Packaging
Any packaging material for pesticide shall pass the UN

Performance Tests on packaging.
The main objectives of the UN performance test are the

following:
1. To make the transport of the products feasible which will in

turn encourage trade.
2. To ensure safety of people, property and environment.
3. To generate data for use as guide in the formulation of

harmonized laws and regulations.
There are three (3) types of test conducted on packaging:
1. Material and Packaging Testing
The objective of this test is to determine the

packaging design and specifications. Examples of
materials being tested for packaging are the following:
• Metal
• Lacquer
• Plastic
• Paper and cardboard.
Examples of packaging testing are the following:
• Water absorption of corrugated cardboard boxes

• Stress crack corrosion on PE-canisters
• Lacquer quality on iron steel drums.
140
2. Compatibility Test
These tests are conducted in order to determine if

the packaging will be able to store its contents under
different conditions and for certain minimum length of time.
Main tests include the following:
• Loss of a.i. content

• Water content loss
• Weight loss or gain
• Appearance of the packaging (including internal
surface)
• Appearance of the closure.
3. Performance Test
This includes the following:
• Drop test
• Leakproofness test
• Hydraulic pressure test
• Stacking test
5.4.2 Regulatory Requirements
A. Pesticide Containers
1. Packaging containers and related outer packaging shall

comply with all national standards and regulations which
apply to packaging and, where required, with international
transportation and safety regulations.
2. Pesticides shall only be packaged in containers designed

to provide protection against product deterioration,
compaction, weight change or any other form of spoilage.
The container used shall be able to withstand all
anticipated levels of handling, storage, stacking, loading
and unloading conditions, and shall not be adversely
affected by changes in atmospheric conditions such as
pressure, temperature and humidity.
3. The inner surface of the container or closure may be

coated or lined with substances or materials which have
been tested to resist corrosion and to be inert toward the
contents.
4. The outer surface of the container shall be made of or be

coated with materials which resist corrosion or other forms
141
of deterioration and are suitable for direct label printing or
the attachment of a printed label.
5. The shelf life of the container and its contents shall not be
less than two (2) years. In case the shelf life of the product
and its active ingredient is less than two (2) years, the
“best before date” (month, year) shall be clearly indicated
on the label. In every case, however, the date of
formulation and batch number shall also be clearly
indicated.
6. Containers of a specific design which have been tested

and qualified for a particular product shall be retested if
they are to be used for another product, or with a new
formulation of the same product. Likewise, should there be
any change in the design, or size and shape, or materials
used in the manufacture of the container, then the test
procedure shall be repeated.
7. Used containers or reconditioned packaging shall only be

reused when its quality has been tested to be equal to that
of the original packaging.
B. Filling
1. Strict quality control shall be instituted in the container

filling sites to maintain the high standard of the pesticide
containers and its contents.
2. All liquid containers shall have a headspace of at least 5%.
C. Types and Specifications of Pesticide Containers
1. Inside Containers
Inside containers are defined as those, which

require an overpack to provide protection during shipment,
handling and storage. Inside containers may be removed
from overpacks for sale or display.
a. Bags containing not more than 10 Kg
Bags shall be constructed of one or more

piles of paper film or aluminum foil. Bags shall be
tested by approved procedures for compatibility
and resistance to impact.
142
b. Bottles containing not more than 1 Kg or 1 L
Bottles shall be fitted with closures, which in

the case of liquid will not exceed 63 mm.
Polyethylene or other plastic bottles used shall be
made from virgin materials and shall have high
level of resistance to environmental stress cracking.
Bottles shall be tested using approved procedures
for compatibility and resistance to impact.
c. Metal containers containing not more than 10 Kg or

2L
Metal containers shall be constructed from
steel, coated with tin or other materials, to provide
compatibility with the content and external
protection. In addition, metal containers for liquids
shall use a gasketing compound at seams, which
are not joined by welding. Metal containers shall
be fitted with closures, which in the case of liquids
will not exceed 63 mm. Metal containers shall be
tested using approved procedures for compatibility
and resistance to impact.
2. Overpacks
Overpacks are defined as containers, such as

boxes or cartons, which provide essential levels of
protection to one or more inside containers. Overpacks
shall be sufficiently rigid to prevent compaction or other
damage to contents. Where required, internal packaging
materials shall be used to help protect the contents.
The quantity of board used for overpacks shall not

be measured as less than 190 g/m² when tested by the
approved procedure.
Overpacks shall be drop-tested while containing

inside containers filled with water or other suitable inert
material using the approved procedure.
3. Bulk Containers
Bulk containers are defined as rigid wall packages

which may be metal, polyethylene or fiber drums or heavy
duty corrugated paper boxes.
Drums containing not more than 250 Kg or 200 L.

Drums shall be constructed from steel, which shall be
coated internally and externally with a rust preventive or
143
corrosion resistant medium. In addition, all seams not
joined by welding shall use a gasketing compound.
Polyethylene drums shall be manufactured from resins with
known high level of resistance to environmental stress
cracking. Fiber drums and corrugated boxes,
manufactured from paper, shall be internally lined with
sealed polyethylene bags having a thickness of not less
than 0.05 mm. The size of closures for liquid containers
shall not exceed 63 mm. Bulk containers shall be tested
by approved procedure for compatibility and impact
resistance.
D. Selection of Appropriate Pesticide Containers
1. Solid Products - Powders, Dusts or Granules
Small packages, usually up to 3 kilos capacity, can

generally be selected from ready made packaging such as
bags, pouches, canisters, cans, glass or plastic jars. Bags
or pouches shall be leakproof. Canisters, cans, and glass
or plastic jars shall have closures, which are of the screw-
on type to prevent leaks.
2. Liquid Products
• Small containers size up to 5 liters capacity can

generally be selected from available stock
packaging. Types used are cans, with necked
bottle, flat or screw top, made of glass or plastic.
• Large liquid containers typically sized between 10

to 200 liters capacity are usually of standard
varieties such as jerry cans and drums
manufactured from steel and plastic. Liquids shall
always be packed in containers with closed heads;
in the case of drums, the head should be seamed
or welded onto the body.
3. Pressure Packages
Containers which must contain the contents under

pressure at ambient temperatures shall be packaged in
containers designed to be pressure resistant. Particular
attention should be given to the gauge of the metal used
for the body and heads, the method of sealing and the
construction of the valve.
144
4. Overpacks
Overpacks are used to hold one (1) or more

containers together and often provide extra protection for
the side containers from handling, stacking and shipping
damage. They can be constructed from film bags, shrink
wrappings, paper bags or corrugated boxes depending
upon the level of protection required. The most commonly
used overpack for pesticides is the box particularly due to
its ability to provide low cost, economic protection.
5. Closures
Selection of the right closure is important to

successful packaging in rigid containers, especially when
they contain liquids. The closure size for liquid containers
shall be determined based on the rate of pour required and
the viscosity of the formulation. Closure size shall not
exceed 63 mm, and it is useful to limit smaller sizes to 38
mm for the purpose of standardization.
Closures for rigid containers for powders or

granules may be larger than 63 mm, often close to, or the
same as the diameter of the jar or drum. Tamper-proof
feature built into the closure which indicates whether the
container has been opened is particularly useful. Closure
liners shall be carefully selected since they influence
greatly the overall performance. Inadequate liners are
often found to be the cause of container defects.
Closures are not designed to be in constant direct

contact with the product except in the vapor phase and
shall not be expected to contain liquids when the container
is inverted.
Closures shall be applied to containers at a torque

sufficient to maintain a seal. It is customary for the torque
originally applied to reduce with time, usually 24 hours.
The correct method of determining the torque is to
measure the opening force.
E. Testing of Pesticide Containers
The performance of tests on containers is a useful means

of determining the probability of the container providing the level
of protection established in these Container Requirements and
Standards prior to initial shipments being made. Subsequent to
production of the product, it is necessary to make confirmatory
tests to determine the efficacy of the original work. The use of
145
specific test procedures improves communication between
interested parties, such as regulatory bodies and container
manufacturers and users. Test procedures can be developed with
varying levels of complexity, depending on the facilities and
personnel available. The determination of successful pesticide
packaging can usually be done by means of practical procedures.
Certain procedures are required in these Pesticide Standards;
other useful procedures can be adopted. However, for reference
purposes, well-established test procedures, such as those
published by A.S.T.M. or other internationally recognized bodies,
should be used.
F. Safety
Development of new ways of packaging pesticides and

choosing the correct one enhances the safety of the user and the
environment. There are several problems in safety which can be
alleviated if not solved by improvements in packaging. The
following are some of the more common problems:
1. User Safety
• User contamination during mixing

• Incorrect dose measurement
• Damage during transport and storage
• Tampering by children
2. Environmental Safety
• Waste disposal
• Recycling
G. Present Trends in Pesticide Packaging
Packaging materials are increasingly selected with ease of

disposal of used containers in mind. This is because it is
becoming difficult for farmers to find safe and convenient methods
for disposing agricultural chemical containers. In order to reduce
waste, recyclable containers are being developed. The use of
biodegradable containers helps reduce environmental pollution.
Packaging materials are also being designed in a way that

makes it easy for the users to transport, measure, mix and apply
the pesticide. Some innovations also reduce the exposure of the
user to the pesticide aside from making it easy for his use.
Many small farmers buy pesticides only at the time when

needed. Limited advance or bulk buying is practiced. The
pesticide is quickly used once purchased. Empty containers may
be rinsed and the rinsate added to the spray mixture. An
146
opportunity exists to design packaging to assist the farmer in
emptying, draining and rinsing the container in his traditional way.
Container disposal is a matter of concern related to its

utility or commercial value. Those with neither utility nor
commercial value are usually found in the corner of fields, in
ditches or at roadsides. However, some find their way into local
use for carrying kerosene and other substances or are into formal
collection channels for recycling or re-use. Re-use by
counterfeiters is a major worry, requiring vigilance. The use of
seals, guarantee rings, shrink wrap on individual packages helps
in deterring people intent on tampering and adulterating the
product. Inclusion of embossing and other special features on the
packaging discourage people intent on duplication. This still
leaves opportunities for misuse of emptied containers for storage
of foodstuffs and repacking of counterfeit products.
Typical strategies for packaging and packaging disposal

for liquid formulations include the following:
1. The use of water-soluble bags, plastic or paper bags as

primary packaging.
2. Development and introduction of refillable containers.
3. Replacement of glass and metal packaging by plastic

containers.
4. Development of appropriate container designs which allow

safe and economic recycling and/or disposal.
H. Squeeze Bottle On or Squbo
The squeeze bottle or Squbo was based on the need to

reduce the risk of contamination for small farmers during
measuring out small amounts of liquid insecticides. Very often,
measuring cups are not available and farmers must use the bottle
cap or a tablespoon to measure the product. The squeeze bottle
offers several advantages:
1. Safer handling during mixing;
2. Accurate measurement of dose;
3. It actively implements Article 5 of the “FAO Code of

Conduct” by reducing end user hazards; and
4. Helps create safety awareness in all levels.
147
I. Water Soluble Bag or WSB
Water-soluble bag is a bag or sachet containing pesticide

usually in gel or liquid form. The bag or sachet dissolves when
dropped in water, thus, releasing the contents. This system of
packaging minimizes the risk of exposure since the user only
handles the bag while it is still non-reactive and is not yet
dissolving. Exposure is also minimized since the user handles the
pack very briefly by retrieving it from its tray and dropping it into
the mixing tank. This is in contrast to the use of bottles where the
farmer is at risk since he has to measure and prepare the
pesticide spray solution before using it.
J. Closed Filling Systems (Farm-Pak/Venturi Pump, etc.)
These systems are bulk containment which has the

following advantages:
1. It is easy to operate and, therefore, reduces working time

and the number of workers needed (one can handle it).
2. There are no leftovers and error in measurement is unlikely

since it uses a digital flow meter to dispense the pesticide
into the mixing tank.
3. The large container is harder to steal than smaller

containers.
4. Refilling under these systems is like filling up your car at

the gas station. It uses a similar closed filling system,
which is easy to use.
5. It is easy to control the stock inventory because of the

digital flowmeter.
6. There is nearly no need to rinse containers.
5.5 TRANSPORT, STORAGE, AND DISPOSAL
5.5.1 Introduction
This section describes the guidelines and regulations for the

transport, storage and disposal of pesticides, recommended methods for
coping with leakage and spill problems, as well as method for disposing
unwanted pesticides and pesticide containers.
148
5.5.2 Transport
Safety in transport, with minimum risk to people and to the

environment, must be a primary consideration for everybody concerned
with the distribution of pesticides. Many of the incidents involving
pesticides, which occur during transport, can be avoided by the following
good distribution practices.
A. Movement and Means of Transport
From the manufacturer or formulators’ depot, pesticides

are transported to distributors who then transport these to
pesticide dealers or retailers.
B. Transport Emergency Card
Drivers of vehicles transporting pesticides shall be

provided with a document (e.g. a Transport Emergency Card)
giving information on the following in the event of an accident:
1. Name and address including telephone number of the

dispatching company.
2. Products being carried.
3. Basic hazards posed by those products.
4. Precautions and actions to be taken in case of accident or

an emergency.
C. Labelling and Packing of Pesticide Containers
All containers shall be properly labelled and packed in

manufacturer’s original container.
1. Since pesticides are often transported over long distances

on bad roads, attention shall be paid to the quality of
packaging. Faulty or unsuitable packaging can lead to
accidental leakage of product during transport and
presents hazard.
2. All products being transported shall be properly and

correctly labelled in order to ensure that the potential risks
are communicated to all who may handle the goods, in the
course of distribution.
149
D. Loading and Unloading
1. Make sure that the correct product is being dispatched and

the cargo is labelled correctly.
2. Under normal conditions, pesticides are stable. However,

if subjected to climatic extremes of temperature or
moisture during transport, decomposition of some products
can occur and the stability of the packaging can be
adversely affected.
To avoid damage due to temperature and moisture

extremes, the following shall be observed:
a. Use only vehicles or transport units that are dry inside.
b. Packaging, including pallets, should be dry when

loaded.
c. Use dry materials for cushioning and securing the load.
d. Pesticides shall be covered during transport to protect

them from rain or direct sunlight.
3. Pesticides shall not be loaded on the same vehicles as

foodstuff and other materials destined for human or animal
consumption and use. If this could not be avoided, be sure
to load the pesticide away from these items.
4. Examine the product carefully before loading. Damaged or

leaking containers shall not be loaded.
5. Load and unload pesticides carefully. Do not load

pesticides on the roof of the vehicle. Watch over the
pesticides during transport.
6. In case of accident (crash, fire or spillage), the driver

should:
a. Switch off the engine and should not light a

cigarette.
b. Send someone to call the police and the pesticide

company, and warn other traffic to keep away.
c. Try to contain the spill by covering it with an

absorptive material like soil or dust. Be careful
about his own and others’ safety. Put on protective
gear and avoid walking in splashes and fumes.
d. Collect the absorbed spill, broken containers and all

contaminated waste for disposal in a safe place.
150
5.5.3 Storage
Good storage of pesticides involves the control of all factors that

may cause deterioration of the stored products. These factors may be
physical (heat, humidity), biological (molds, insects), chemical (acidity,
corrosion) or mechanical (pressure packing). Even under optimum
storage conditions, some products may spoil after a period of time.
A. Safe Storage System
1. Pesticide storage areas shall be constructed and

maintained so that the risk of contamination to other
products is avoided. All pesticide storage areas shall be
clearly marked with warning signs.
2. Storage systems shall be flexible in view of changing stock

quantities. They shall also be adaptable to the storage
structure.
3. The system shall provide for orderly stacking and shelving

with sufficiently wide gangways to enable access to and
easy movement of stocks and minimize the risk of
contamination from handling pesticide containers.
4. Pesticides shall be stored in containers with original label,

positioned so that the label is clearly visible. Stock shall be
arranged so that the “first in, first out” policy is followed.
5. Keep floor space clear and uncluttered, with gangways

between stacks and shelves for easy inspection and good
ventilation.
6. Keep doorways and fire exits free from obstacles, also

keep access to the washroom and fire station free.
7. Do not store pesticides and contaminated empty pesticide

containers near food and animal feedstuffs, seeds and
other plant materials, beverages, clothing and other such
articles.
8. Separate pesticides into product types such as herbicides,

insecticides and fungicides, and allocate separate stacking
areas for each type.
9. Segregate the more toxic products and the combustible

ones in separate sections of the warehouse, preferably
separated by firebrick walls.
10. Stack solid products separately from liquid products.
151
11. Never place containers of pesticides directly on the floor.
Use dunnage (bricks, pallets or timber) under the
containers so that leaks may be discovered easily.
Dampness from the floor or leaking pesticides will lead to
corrosion of containers and more leakage.
12. Larger containers, such as drums, bags and boxes, may

be stacked in a manner that the stacks are stable and
sufficiently low to enable easy handling.
13. Dust, granule and wettable powder formulations may cake

under pressure. Store and stack these formulations in
their original cardboard or fiber containers to prevent
compression. If such formulations are supplied in bags,
they should not be stacked high.
14. Small containers may be stored on shelves, which should

not exceed two (2) meters high; this precludes the use of
ladders. One should not climb on pesticide containers to
reach other stacks.
15. Mark all warehouse sections and stacks of products with

waterproof sign indicating the contents.
16. Keep accurate account of all stock movements and

inspection.
B. Storekeeping
1. Pesticide Shelf Life. Proper management shall always

consider the shelf life of the products. The store manager
or storekeeper shall only order stocks which can be sold or
disposed within a reasonable period of time before the
“best before date” of the product. He should avoid
ordering too much of slow-moving items.
2. Inspection of Stocks. All stocks shall be regularly

inspected for signs of deterioration or leakage. Points to
watch out include:
a. Strong odor, which often indicates leakage or

product decomposition.
b. Metal drums which are susceptible to rusting and

leaking seams or dents.
c. Plastic drums or bottles shall be inspected for

deformation and leakage.
152
d. Carton and boxes, and paper or plastic sacks shall
be inspected for dampness and discoloration, holes
and signs of leakage.
e. Glass bottles shall be inspected for cracks or

leakage.
f. Missing lids or labels.
Whenever deterioration or leakage is detected or

suspected, all affected packs shall be removed and
isolated. Neighboring packs shall be carefully inspected
and removed for cleaning if they are contaminated.
3. Rotation. Pesticide stocks shall be rotated on a first -in-

first-out basis. “Older” stocks shall be sold or disposed first
before the newer stocks.
C. Recording System for Stored Pesticides
The basic principle in any storage operation is rotation of

stocks on a first-in-first-out basis. Although the type of record
system adopted will depend on the size and functions of the store,
there are certain practices that must be followed in all pesticide
stores.
1. Keep accurate record of all stock movements and

inspection. Write the date of purchase or the date of
receipt on each container immediately upon its arrival in
the store.
2. Ensure that containers are properly labelled: that the

labels remain on the containers, and that they are clean
and readable. Labels in poor condition shall be replaced.
3. Outdated stocks. Information on shelf life shall be

requested from the distributor at the time the pesticide is
purchased.
4. Write-off. Pesticide products which have expired or have

reached the end of their shelf lives shall be written-off or
removed from the inventory of stocks. They shall be
disposed in accordance with the section on disposal.
D. Safety Requirements for Storage Personnel
1. All personnel in a pesticide store shall receive proper

instruction and on-the-job training before they are allowed
to work in a storage area. Knowledge and skill levels need
to be tested periodically.
153
2. Appropriate protective clothing shall be worn; a respirator
shall be used whenever recommended. Protective apparel
and instruction in its proper use shall be provided by the
employer.
3. Do not work alone when handling very dangerous

pesticides.
4. Do not permit smoking, eating or drinking in pesticide

warehouses and storage areas.
5. Practice good personal hygiene; wash work clothes

frequently. (Clean water and soap shall always be
available for this purpose).
6. Inspect pesticide containers for leaks before handling

them; avoid leaving containers open. In order to prevent
damage, never handle containers roughly or carelessly.
7. Should leak or spill occur, keep people and animals away

from the area and give priority to thorough
decontamination of the area.
8. Always keep material use for dealing with spillage and

decontamination on hand. For larger warehouses, have
this equipment available at strategic points.
9. Always make available in the storage area dry-powder fire

extinguishers or substitute such as sand buckets, for
fighting small fires. Train all personnel in dealing with
small fires.
E. Recommendation for Safety in Shops
1. Because pesticide shops are often located near the town

center, attention shall always be given to fire prevention.
2. Highly poisonous pesticides shall be stored behind glass

doors on shelves or in glass compartments or cupboards,
preferably under lock and key.
3. Display a “DANGER, POISON” notice outside and inside

the shop so that it can be seen immediately.
4. All containers, packs and bottles shall carry a complete

label, preferably in the major national language(s), which
can be understood at least by the shop manager.
5. Pesticide containers and bottles shall not be piled upon the
sales -counter where they can be easily knocked over.
154
6. Do not keep too many containers of the same kind in the
shop area. Keep your stocks in a separate store.
7. Customer shall not be allowed to open containers to smell

the content because they might be poisoned by inhalation.
8. Ensure that pesticides taken by the customer from the

shop to the farm are wrapped adequately and carried
separately from food, drinks and other consumer articles.
Do not sell pesticides in leaking containers.
9. Do not hand over dangerous pesticides to children sent by

parents or others to collect such products.
10. Store adequate supplies of water, soap and towels ready

for use by customers in case of contamination.
11. Do not allow customers to use pesticide shop as a place

for lengthy conversations or friendly gatherings.
5.5.4 Leaks, Spills and Decontamination
A. Leakage and Spills
1. Leakage is a major problem in the storage and transport of

pesticides. Causes of leakage are the following:
a. Rough handling - dents weaken or split seams and

weaken closure (lids, caps, stopper) of drums.
b. Puncturing or abrasions during transport when

containers rub against each other or against sides
of truck. The use of hooks for unloading bags at
inland ports may damage bags.
c. Corrosion of the container, which may be

accelerated as a result of physical damage.
d. Strong sunlight may degrade some plastic

containers including plastic bottles and plastic
sacks.
2. Spills should be cleaned up immediately to prevent harm to

people and animals, and to avoid contaminating the
environment.
As soon as spillage occurs, or a leak is noticed;
155
a. Keep unauthorized persons, children and animals
away from the affected area.
b. Prevent further waste by closing the container

properly, or shifting its position to stop a leakage, or
placing into another container.
c. With dry waste, such as powders and granules,

cover with dry sand or soil and sweep up and
shovel into containers with cover for safe disposal.
The use of damp sand or water may release toxic
or flammable gasses from certain products.
Consult the label.
d. With liquid waste, use lime, sand, soil, or any other

absorbent material to soak up the spillage. Shovel
this into containers with cover for disposal.
e. Wash the contaminated spillage area thoroughly

with water. Do not allow the wash water to run off
into any sewer, stream, well or pond and if
necessary soak it up with more absorbent material
for disposal.
f. Make sure that all other containers near the

spillage area are thoroughly decontaminated by
thorough washing. Dispose off the washings
properly.
3. During all handling operations of spillage and leaks,

protective clothing such as gloves, boots and eye
protection, as recommended on the product label, shall be
worn.
Protective cleaning gear shall always be kept ready

in warehouses, stockyards and shops for dealing rapidly
and effectively with spillage and leaking containers.
The following list of equipment shall be sufficient to

enable someone to deal with common accidents of spillage
and leakage:
a. Two pairs of neoprene or PVC gloves (elbow

length)
b. Two pairs of rubber boots
c. Two neoprene or PVC aprons; a meter wide and l.5

meters long
156
d. Two respirators, canister type
e. Two face shields, helmet type covering eyes and

face or at least two pair of well-fitting goggles
f. Fifty Kg. of powdered lime (as a general purpose

absorbent for liquid pesticides), or sawdust, or
sand, or other absorbent material
g. Five liters of Teepol, or washing soda (sodium

carbonate) or strong soap
h. Two-yard brooms
i. Two shovels
j. Some empty decontaminated drums of various

sizes for waste disposal and repacking
k. Paper labels and glue for marking drums and boxes
l. Funnels, buckets, drum spanners and earthen wire
B. Decontamination of Personnel (Skin)
The most common contamination to people in the case of

leakage and spillage is skin contamination. Successful
decontamination requires:
1. Washing with plenty of soap and water.
2. Extreme thoroughness in using the soap and water.
3. Great speed in washing with soap and water.
5.5.5 Disposal of Pesticide Wastes
A. Methods of Disposal
1. High Temperature Combustion
Some pesticides need very high temperatures to

destroy them. These cannot be achieved in a bonfire. As
a general rule, it is safer for pesticide wastes to be burnt in
high temperature combustion facility licensed for the
purpose.
If there is no licensed facility within the area and if

the amount of waste to be disposed of is not excessive, a
157
bonfire maybe used. Extra care must be taken so that
there is no risk of smoke and fumes drifting downwind to
affect people, animals, houses or any other inhabited
buildings or plants. There must also be no risk of the fire
getting out of hand and spreading.
The bonfire site shall ideally have an impermeable

floor and a containment sill. For smaller quantities, a
perforated steel drum should be used. Products that
contain highly chlorinated materials or heavy metals
(especially mercury) must not be burnt in an open fire.
The fire shall be kept very hot, with plenty of dry

combustible materials, such as brushwood and timber, or
alternatively, with kerosene or used motor oil in a drum.
The waste shall be carefully fed to the fire in small
portions, allowing each portion to be fully consumed before
adding the next. In order to achieve the most complete
burning, the glowing ash shall be stirred mechanically
before it is removed. The ashes from the bonfire shall be
buried, as described in the following section, since they
may contain undestroyed pesticide residues.
2. Burial
a. Licensed landfills
In the absence of a licensed incinerator and

where burning on the farm is not permitted or is not
practical, pesticide waste maybe disposed of in
landfill site, provided it is licensed for the purpose.
If the site operators will collect waste in their

own specialized vehicles, this will minimize the
problems of spillage and leaks during transport.
The site operators shall always be notified of the
identity of the pesticide waste.
b. Burial on the farm
In the absence of a licensed high

temperature combustion facility or landfills, it
maybe necessary to dispose off small quantities of
waste by burial on the farm.
Burial shall be done in a small pit, with the

following precautions strictly observed.
158
• Drainage or seepage into water courses or
sources of drinking water shall be avoided;
and
• Burial shall be deep enough and the site

adequately fenced off to ensure that human
and animal activities will not uncover the
pesticide wastes. The site shall be clearly
labelled with warning signs.
The disposal pit shall ideally be located on a

high flat land and where the sub-soil will permit a
limited but slow permeation and biological
degradation of the pesticide; thus, excessively
sandy sites shall be avoided. The area chosen
shall not be subject to flooding and shall be located
well away, at least 15-30 meters, from streams,
springs, ponds and wells. The bottom of the pit
shall be located at least 2 meters above ground
water level. The pit shall be in the form of a bowl
with a diameter of 2-3 meters and a depth of 1-1.5
meters. An additional area shall be reserved along
side for a second or third pit for future use. Initially,
the pit shall be lined with 5-10 cm depth and
intermixed with lime and biodegradable household
wastes to assist biological degradation.
Concentrated wastes shall be diluted with

water before disposal. On completion of each
deposit, a layer of compost or soil should cover the
waste to prevent risk of contact and to provide a
source of nutrient and microorganisms for biological
degradation. Fill the pit and allow the room for a
final layer of 50 cm of compacted compost or soil to
top it off. To avoid rapid drainage of water into the
subsoil, the top should be planted with brushes.
The second pit should be excavated and operated
in a similar manner.
The waste area shall be carefully fenced off

and labelled with warning signs. The composition
and date of each deposit consigned to the pit shall
be recorded.
B. Disposal of Pesticide Containers
Contaminated containers shall be cut open, ruptured or

crushed before disposal.
159
1. Decontamination
In general, all used pesticide containers shall be

decontaminated before disposal. The three (3) stages for
decontamination are:
a. Empty the contents of the container into the mixing

tank, and drain for 30 seconds;
b. Rinse container at least three times with a volume

of water not less than 10% of the container’s total
volume; and
c. Add the rinsate each time to the mixing tank.
Rinsing will not render any pesticide container

suitable for use for storage of food, feed or water for
domestic consumption.
2. Disposal Methods
a. Combustible containers shall be burnt except

where, in the case of some herbicides, labels warn
against burning (see below). Burning shall be
carried out where wind will not cause contaminated
smoke to drift over nearby homes, people,
livestock, crops or the persons doing the job.
Some municipalities have restrictions against
burning; local authorities shall, therefore, be
consulted before burning pesticide containers.
Caution: Drums or bottles may be under the pile to

be burned. Ensure that caps are removed, or that
containers are punctured to prevent explosions.
b. Non-combustible containers
Large containers: after rinsing as above, 50 L and

200 drums shall de disposed of in one of the
following ways: (a) return them to the supplier at
the cost of the user; or (b) sell them to a firm
dealing with used drums or barrels that is equipped
to neutralized the toxicity of adhering materials; or
(c) take them to the sanitary landfill type of dump.
Inform the operator of the dump that the drums
contain residues of poisonous materials; warn him
that poisonous vapors may be produced if the
containers are burned. Before leaving, remove lids
or bungs from the containers; chop holes in the
containers with a sharpened pickaxe to prevent re-
160
use. Make sure that the site cannot contaminate a
water supply; or (d) if none of the preceding
disposal means are available, find a private
disposal site of the type described above which you
will use only for empty containers and unwanted
pesticides. Correct site selection is most important.
c. Small containers: After rinsing, as above, small

containers maybe disposed at public dump or
buried at least half a meter deep at private disposal
site. First, remove the caps or lids, punch holes in
metal containers, and break glass containers. Do
not use containers for storage of food, feed or
water for domestic consumption.
d. Herbicide containers: disposal of some herbicide

containers, particularly for those phenoxy-acid
herbicides, requires extra care to prevent crop
damage. Take the precaution of triple rinsing as
above, before disposal preferably tipping the rinse
into the spray vat for use. If this is not possible, tip
rinse water into the disposal pit. Disposal of
herbicide containers can then proceed as follows:
• Burn containers except where labels advise

against it. When some herbicides or
defoliants volatilize, the resulting vapors
may be poisonous to humans, or they may
damage nearby crops or shrubbery.
Herbicides or defoliants containing chlorates
may explode when heated.
e. Retrieval of pesticide containers shall be made as

part of the responsible care program for each
pesticide company.
5.6 OCCUPATIONAL HEALTH
Occupational health staffing and training of occupational health staff shall

be in accord with Section 1963.02 of Department of Labor and Employment
(DOLE) regulations for first-aid workers, nurses and physicians.
5.6.l Safety/First Aid Training
A. Occupational Health Personnel
Physicians and nurses working in establishments where

pesticides are used shall be accredited by DOLE. The company
161
shall submit certification to the FPA. Other paramedical staff shall
be trained and accredited by the Philippine National Red Cross
(PNRC) or by the Safety Organizations of the Philippines (SOPI).
B. Workers
All workers (regular, contractual, permanent and casual)

handling pesticides shall undergo pre-placement and periodic
training on the proper and safe handling of pesticides; proper use
of personal protective clothing and equipment, basic knowledge of
the chemicals they are handling and first aid procedures in cases
of poisoning. Periodic general safety training shall be conducted
for a period of eight (8) hours per year or two (2) hours per
quarter. Specific workplace hazards shall be communicated to the
workers to ensure compliance.
5.6.2 Health Examinations
Pre-placement, periodic and exit health examinations are required

for all permanent, contractual and casual personnel working with
pesticides. Health examinations shall consist of the following minimum
requirements which shall be provided by the employer free of charge: a)
complete physical examination which shall be properly recorded and kept
in the clinic, b) laboratory tests, and c) biologic monitoring.
Workers exposed to Categories I and II pesticides shall have

semi-annual examinations consisting of a complete medical examination,
hematologic, liver and kidney function tests. Workers exposed to
Categories III and IV shall have annual medical and laboratory
examinations.
To ensure the safety of the workers, only regular personnel shall

be allowed to work in formulating/manufacturing plants and institutions
handling Categories I and II pesticides. Casuals shall not be allowed to
handle AI or technical materials.
5.6.3 First Aid
An emergency clinic shall be provided for all hazardous

workplaces regardless of the number of workers. There shall be
minimum personnel requirement for plants/plantations/pest control
establishments handling Categories I and II pesticides.
5.6.4 Safety and Security in Plants/Plantations/Pest Control Establishments
Emergency equipment to meet accident needs shall be provided

such as emergency showers and eyewash facilities. In plantations or in
162
the field, there shall be provision of water at work area of 25
gallons/person or minimum of 100 gallons per area, whichever is greater.
Maintain safe work environment by requiring health personnel to

conduct regular appraisal of workplace including all the facilities therein in
order to detect occupational health hazards. The physician shall be
informed of the exact time, place and the type of pesticide to be used
including the number of workers exposed.
Fire-fighting equipment shall be provided and strategically located.

Signs indicating smoking restrictions, access restrictions, the location of
the emergency equipment, re-entry time, and all escape routes shall be
prominently displayed.
Each team of workers shall have at least one (1) person trained
on first aid treatment of poisoning.
All emergency and safety-related equipment shall be frequently

and regularly checked and maintained. Records shall be kept of all
inspection checks and maintenance carried out on the equipment.
These records shall be made available and ready during inspections.
163
Chapter 6
POST REGISTRATION ACTIVITIES
164
FPA has the authority to conduct a wide range of activities after a

pesticide is registered to assure that it is being handled, distributed and used
safely and in accordance with the applicable rules, regulations and product
labelling. The more important functions for the registration and licensing
programs are discussed. However, FPA post-registration activities are not
necessary limited to these.
6.2 MONITORING ACTIVITIES
Monitoring activities to ensure enforcement of policies at the local level

shall be done in coordination with the pertinent offices under the Local
Government Units (LGUs) and community-based people’s organizations.
The mayor and barangay captains shall be given police power to enforce
these rules and regulations in behalf of FPA. The barangay secretary,
agriculture or health sector representative of the Sangguniang Barangay shall
keep records of monitoring activities, including but not limited to pesticide
poisoning cases, and unusual environmental conditions that are directly
attributable to pesticide use/ contamination. These data will be submitted to the
Mayor’s Office on a quarterly basis.
The Municipal Agriculture Officer (MAO) as defined by a Memorandum of

Agreement shall be responsible for the collation of barangay data. In addition,
the agriculture technicians shall monitor compliance with rules and regulations by
the dealers in their area of jurisdiction. Violations shall be reported to the
Provincial FPA Officer. In turn, the Provincial FPA Officer shall send the data to
the FPA Regional Officer for transmittal to the FPA central office. This is to be
done on a quarterly basis. The Field Operations Division, in coordination with the
Planning and Information Division of FPA, shall create the database for the data
coming from the field. Results of monitoring shall be presented during PPTAC
meetings, whenever necessary.
A prescribed form (Annex XII) will be used for monitoring activities in the
barangay and town/city levels. FPA shall deputize Provincial Agricultural Officer
(PAO) and/or MAO to monitor the problem areas. Important data to be collected
at the barangay level are popular types of pesticide used, report on incidence of
pesticide poisoning in relation to specific pesticides and mode of use, extent of
use of banned chemicals, extent of pollution in the environment measured by bird
kill, fish kill, color of surface water, taste of ground/potable water, and other
manifestations of pesticide effect on public health and the environment.
Data generated in monitoring food and environmental contamination shall

be reported to the FPA on a quarterly basis by the laboratories around the
country that are assigned for that purpose.
Regional FPA Officers are tasked to monitor compliance of distributors,

manufacturers and importers regarding rules and regulations. Data generated in
165
these monitoring activities shall be used as a basis for the renewal/revocation of
licenses.
6.3 COMPLIANCE IN MONITORING OF PRODUCT STEWARDSHIP
6.3.1 Monitoring of Product Quality
FPA shall establish a mechanism to ensure that the product has

not yet expired, not misbranded or adulterated.
Expired formulated products shall be recalled and collected by the

company concerned. Adulteration/faking/misbranding/mislabelling of
pesticide products are acts prohibited by P.D. 1144 and the Implementing
Rules and Regulations and are subject to the penal provisions of the law.
6.3.2 Residue on Food and Feeds
FPA shall establish a rapid monitoring system of pesticide

residues in food crops and feeds to provide information that shall be used
to assess the safety of the consumers. Such residue data shall be the
basis for modifying use patterns and taking regulatory action on the
particular pesticide.
FPA network of residue laboratories shall monitor pesticide

residues in food crops and feeds.
6.3.3 Environment
FPA and other concerned agencies (LGUs and NGOs) shall

monitor pesticide movement to the farms and other areas to determine
the potential polluting and contaminating effects on natural environments
which may affect fish, wildlife and other non-target organisms. Evidence
of such impact shall lead to regulatory action on the pesticide.
Monitoring shall also be required of the registrant as a condition

for registration of a particular product when this presents a practical way
of resolving technical or environmental issues.
6.3.4 Pesticide Poisoning
FPA shall institute a mechanism to monitor pesticide poisoning at

the barangay level in coordination with the concerned agencies. A
Memorandum of Agreement between the FPA and the concerned
agencies shall be established.
166
Monitoring pesticide poisoning cases shall be done through the
Municipal Health Officers, physicians and paramedical practitioners
trained under the Agro-Medical Training Programme. Monthly reports
which are collected annually shall be submitted to FPA. Institutions
allowed to handle pesticides restricted to “For Institutional Use Only” are
also required to submit monthly reports on pesticide poisoning cases.
FPA Provincial and Regional Officers and pesticide companies

shall coordinate with the Department of Health (DOH), Regional
Occupational Toxicology and Non-Communicable Disease Information
Center (ROTNIC) as well as with the Regional Strategic Tactical
Operational Program on Disaster, Epidemics, Accidents, Trauma and
Hazardous Substances (STOPDEATHS).
All pesticide poisoning cases shall be properly documented using

the WHO-GCPF protocol. Data shall be submitted to the municipal health
units.
6.3.5 Use Patterns
FPA shall actively involve the industry, NGOs, LGUs and civic
organizations in monitoring pesticide use to ensure alignment with label
directions.
6.4 PESTICIDE RESIDUES (MRL ESTABLISHMENT)
A. Legal Basis
Pursuant to Section 6, III (2) and (4) of the P.D. 1144, in

order to protect the public against potential hazards of pesticide
residues in food, FPA is mandated to establish a system of setting
maximum residue limits (MRLs), applicable for both domestic and
imported raw agricultural commodities. Special provisions shall
apply to import and export crops, as well:
“ ... To establish and enforce tolerance levels and

good agricultural practice for use of pesticides in
raw agricultural commodities;
xxx xxx xxx
..... To prevent the importation of agricultural

commodities containing pesticide residues above
the accepted tolerance levels and to regulate the
167
exportation of agricultural products containing
pesticide residue above accepted tolerance levels.”
B. Implementation Scheme
Upon its development, the MRL system will be introduced

on a trial basis for one (1) year to educate affected parties and to
ensure its proper implementation. This is to avoid disruption of
agricultural production and confusion among producers, food
importers and exporters.
6.4.2 Guidelines for Establishing MRLs
Until such time that FPA shall have developed an MRL system in
the Philippines, FPA shall adopt the Codex MRLs to protect consumers
from unhealthful levels of pesticide residues. However, for future uses of
pesticides on food crops, registration shall not be granted without a
proposed MRL to cover residues of the pesticide in each commodity for
which registration is requested. Proposed MRLs shall be validated
following FPA-approved guidelines.
FPA shall review the list of Codex MRLs based on the

extrapolation and estimation of allowable daily intake of pesticide
residues from calculations taking into account food factors, dietary intake
studies and safety factors. The procedure for calculating the estimated
daily intake and MRL are summarized as follows:
Total Food Intake

TMRC = ∑(FFi x MRLi) x -------------------------------------
i
Wt. of an adult (or child)
where:
TMRC - Total Maximum Residue Concentration
FF - Food factor
MRL - Maximum Residue Limit
i - the food in question
Total Food Intake
TMRC = ∑(FFi x MRLi )x -------------------------------------
i
Wt. of an adult (or child)
A sample calculation:
Total Food Intake = 900 g/day; adult wt. 60 Kg
168
Crop FFi (Kg) MRL (mg/Kg) FFi x MRL
Rice .33 5 1.65

Lettuce .03 20 0.60
Milk .10 .02 0.002
All Other .54 No. MRL
Crops No Use of the Pesticide
2.252 mg
2.252 mg x 0.9 Kg/day

TMRC = ----------------------------------- = 0.03378 mg/Kg b.w. per day
60 Kg.b.w.
If Acceptable Daily Intake (ADI) for this specific pesticide set by

Codex for example is .05 mg/Kg b.w. per day, then, there is no problem
because the obtained TMRC is 0.03378 mg/Kg b.w. per day which is
below the set ADI.
However, if the ADI is 0.01, this is an indication that the MRL is

too high and should be modified.
From time to time, an existing MRL may be modified to reflect

better current good agricultural practice. These guidelines provide
instruction on what must be provided to FPA to take such action.
A. Establishment of MRLs
1. MRLs are initially to be established by these Guidelines.
2. MRLs may be modified as found necessary both during

and after the trial period.
3. Group MRLs will be established when sufficient data on

representative crops show sufficient similarity to permit
extension. Crop groups are found in Annex XI.
4. Additional crops may be added to groups either by FPA

initiative or upon petition by a registrant or user.
Supporting information may be submitted with any petition.
5. Additional MRLs or exemption may be established in the

future by FPA on its initiative or by petition of a registrant
user, importer or exporter. The petitioner must propose
an MRL or an exemption and must submit data or
information with the petition which:
169
a. demonstrate the adequacy of the proposed level or
justifies exemption;
b. demonstrate the safety to the public health of the

proposed level or exemption; and
c. show the need for the tolerance or MRL/exemption.
6. To the extent possible, MRLs shall be consistent with

those established through the Codex Alimentarius.
7. Once MRLs have been established, no registration shall

be granted for a pesticide product unless its active
ingredients have MRL or exemptions.
8. Violations will be dealt with as any other violation of P.D.

1144.
9. Special provisions for export: Exports must meet the MRL

requirements of the importing country.
B. Establishment of MRLs for New Pesticides for Use on Food Crops
The following data or information are required for establishment of

MRLs:
1. All data required for registration.
2. A suggested MRL.
3. Information or data to support the proposed MRL. These

shall be one or more of the following:
a. Valid supervised pesticide residue trials conducted

in the Philippines following “FAO Manual in the
Submission and Evaluation of Pesticide Residue
Data for the Evaluation of Maximum Residue
Levels in Food and Feed.” Accepted test protocols
may be found in Codex Guidance on Field Trials by
Bates, or the compatible US EPA Guidelines for
Residue Trials.
b. Valid supervised pesticide residue trials conducted,

following the aforementioned FAO Manual, in the
country of similar climate and agricultural practices
and use pattern as those of the Philippines.
Bridging data in the Philippines may be required for
crops which are exported or which form a large
proportion of the Philippine diet.
170
c. Evidence that the proposed MRL is approved by
the Codex Committee on Pesticide Residue
(CCPR) at Step 6 or above and has not been
grossly criticized. Bridging data in the Philippines
may be required.
d. Evidence that an MRL exists in another country

with supporting information to demonstrate its
applicability to the Philippines. Bridging data may
be needed.
4. Information on residues that are likely to be found on the

commodity, as consumed.
5. Information on methods of reducing the residues on the

commodity if it is found to exceed MRL.
6. An analytical method capable of detecting the residue

levels in the crop at the proposed MRL.
7. Information that may be requested:
a. Toxicology data suitable for establishing ADI or

NOAEL, or
b. An ADI established by the Codex, WHO, IPCS or a

country having an FPA accepted procedure for
determining ADI. A list of such countries currently
includes: US, UK, Canada, Germany and France.
Others may be acceptable, however, a WHO value
is preferred.
These may be requested when FPA has no valid NOAEL

or ADI currently available to it through normal registration
process.
8. Crop definition for analysis is the Codex definition unless a

waiver is requested and obtained to deviate for the crop
and MRL in question.
9. Animal feeds also require a proposed MRL and supporting

data for animal products - meat, milk, eggs, etc. - which
may be expected to carry over residues from feeds. This
may require large animal metabolism and residue studies.
C. Clearance of Inert Ingredients
Inert ingredients may not contribute to bioefficacy but may

be toxic to humans. Clearances comparable to the pesticide
171
active ingredients are required unless an exemption from the
requirement is requested and granted.
6.4.3 Exemption from the Requirement for an MRL
An exemption from the requirement for MRL may be granted upon

acceptance by FPA of evidence that a material is of such toxicological
nature, that MRL is not required to protect the public health and safety.
This may be demonstrated by:
1. Toxicity data developed by acceptable protocols - OECD, FAO,

US-EPA, etc.
2. Evidence of limited exposure no matter how it is used due to rapid

degradation.
3. Evidence of minor incremental exposure when compared to

general exposure of population for all sources.
4. Being in the exempt list of pesticides “generally regarded as safe”

by WHO, or by a country having an FPA-accepted system for
reviewing and granting exemptions.
6.4.4 Petition to Change Existing MRLs
The requirements are the same as those for Establishment of

MRL for new pesticide except for those data that FPA already has.
6.4.5 Crop Groupings
Crops have been placed in groups to facilitate the extrapolations

of MRLs and reduce the time and expenses for data gathering. When
MRL exists for representative crops defined for each group, they may be
extended to the whole group of commodities. Crop groupings and
representative crops are found in Annex XI. Petition may be made to add
new crops to these groups.
6.4.6 Proposed MRLs for the Philippines
The new list of the proposed MRLs shall be prepared and

submitted for industry review and acceptance. Once accepted, the list
shall be annexed and shall form part of these Guidelines.
172
6.5 INSPECTION OF HANDLERS
Handlers (dealers, distributors, formulation plant owners, manufacturers,

importers and PCOs) shall be inspected periodically without notice to determine
compliance with P.D. 1144 and its applicable rules and regulations. In particular,
attention shall be paid to proper storage, unregistered products, fake products,
maintenance of appropriate records, and sale of restricted pesticides.
Inspection shall be scheduled on a priority basis where violations have

been reported and to establishments with history of violations. Random
inspection shall be made of other facilities as time permits so that they are all
visited within a year.
All pesticide handlers and Pest Control Operators (PCOs) must make
available to FPA upon request all books and records kept as a normal part of
day-to-day business and related to pesticide purchases, sales and use.
Data, which are trade secrets, commercial or financial information, shall

be protected from release by FPA. In addition:
1. Those selling pesticides must keep a record of all sales of restricted

pesticides including name and address of purchaser and name and
quantity of restricted product. Total record of sales must equal the total
purchases by seller (adjusted for inventory charges and spillage).
2. CPAs shall keep records regarding treatments with restricted pesticides.

Such records may be maintained in any format and must include name
and address of treated property; type of treatment performed; name and
amount of pesticide used (product name, active ingredient name, Kg a.i
equivalent); and the date treatment was performed. A suggested format
for reporting appears as Annex XII.
6.6 IMPORTATION
No pesticide shall be imported into the country without the appropriate

Certificate Authorizing Importation of Pesticides (CAIP) issued by FPA. Pesticide
Circular No. l, Series of l981 lists the following requirements for importation of
pesticides:
1. The importer must be licensed by FPA.
2. The pesticide product(s) and active ingredient(s) must bear a registration

number, or covered by an appropriate Experimental Use Permit.
3. The following must be specified in the request for importation:
a. product, specifying % purity if technical material or active

ingredient if formulated product
b. unit price
173
c. quantity
d. payment terms
e. country of origin
f. destination
g. carrier/vessel
4. The pro-forma invoice must be attached. This shall enable FPA to

correlate the source of supply to the registration of the product.
5. The bill of lading, which verifies that the above transaction transpired at
the term(s) and price(s) stated on the pro-forma invoice, must be attached
to the subsequent request for importation.
All unused CAIPs must be returned to FPA at the end of each quarter.
Processing of import permits by the FPA is based on registration and

licensing policies. No importation of locally produced technical grade material
and its corresponding finished products is allowed by the FPA. However, the
manufacturer is required to submit proof that the price of the technical material
locally produced is competitive with the world market price.
Banned pesticides, if procured through importation, shall be transported

back to the country of origin. This shall be certified by the Philippine consulate in
the receiving country as a proof that such products really arrived there.
6.7 STORAGE AND DISPOSAL OF BANNED PESTICIDES
FPA shall allow six (6) months, from the date of publication of banning
order, to bring the banned pesticides to centralized warehouses in the regions
and finally to Metro Manila. Banned products can either be disposed by
employing high temperature combustion facility or exported depending on the
volume. Banned pesticides shall be transported to another country provided that
the Prior Informed Consent (PIC) principle is followed and that the FPA is the
lead agency to do this. Companies that sold the banned pesticides shall have
the responsibility to retrieve the products.
6.8 DATA COLLECTION
Collection of data on importation, production, sales and poisoning cases

is one of the important activities of FPA. Through issuance of CAIP for all
pesticides imported into the country, FPA has acquired a built-in mechanism for
collection of data on imports of technical materials and finished products. In
addition, the monitoring activities provide a feed-back mechanism for reports on
sales, poisoning cases, and production in formulating plants. The pesticide
companies shall submit annual sales statistics including sales volume and prices
for each of their products to FPA on a regular basis.
174
The data are summarized on an annual basis and maybe released to
interested parties, subject to conditions stipulated in Section 2, Article VI of the
FPA Rules and Regulations No l, Series l977 on “Protection of Trade Secrets
and Other Information.”
6.9 TRAINING AND EDUCATION
1, FPA shall promote Agro-Medical Training in coordination with DOH

specifically on the management of pesticide poisoning cases.
2. FPA shall confer with the Department of Education (DepEd) to explore

the possibility of introducing the safe use of pesticide in the elementary
and secondary school curricula, through incorporation in agriculture-
related subjects. Likewise, FPA shall also discuss with Commission on
Higher Education (CHED) the possible inclusion of pesticide poisoning
management in the regular medical school curriculum
3. FPA shall establish linkage with the Local Government Units (LGUs) in
training the farmers, health workers and others. Likewise, it shall assist
LGUs, DA, RFUs in the establishment and operation of plant health
clinics where the farmers could refer their problems and also in the
conduct of training of technicians by appropriate agencies.
175
Chapter 7
PENALTIES FOR VIOLATIONS
176
7.1 PRE-REGISTRATION
Failure of the manufacturer or company to submit all the required data

and information on the product to be registered and failure to follow the
prescribed pre-registration procedure is a valid reason for FPA not to accept the
application for product registration.
7.2 GROUNDS FOR REVOCATION OF LICENSE
All types of licenses issued by FPA may be revoked, cancelled or

suspended on the basis of any of the following:
1. False statements in the application or any required report or record.
2. False claims in advertisement.
3. Violation of or failure to observe FPA rules and regulations.
4. Refusal to allow inspection.
5. Commission of prohibited acts under PD 1144.
Grounds for Revocation of Accreditation of Certified Pesticide Applicators

(CPAs) and License of Pest Control Operators (PCOs)
Licenses of PCOs and/or accreditation of CPAs are subject to revocation

or suspension on the basis of any of the following:
1. Any of the reasons stated above for revocation of licenses in general.
2. Acts of dishonesty, fraud or deceit.
3. Ignorance or negligence resulting in poisoning or death of his client or

harm to the public by his/her direct action or through persons under his/
her supervision.
4. Application or supervision of the use of any restricted pesticide in a

manner inconsistent with its labelling.
5. Non-compliance with required safety equipment and/or operation of faulty

or unsafe equipment causing injury or death of the client, applicators or
service technicians.
The licensee shall be notified by certified delivery, of the revocation or

suspension of his/her license. He/she shall be given a hearing before FPA gives
its final revocation order. Such hearing must be requested formally within ten
(10) days from the receipt of notice. A PCO or CPA may be suspended pending
hearing for revocation of his/her license or accreditation.
177
7.3 POST-REGISTRATION
Product Stewardship and Responsible Care Violations. Any violation

of the provisions of the policy guidelines on Product Stewardship and
Responsible Care shall be subject to revocation and cancellation of registration
permit and/or company license.
7.4 ENFORCEMENT OF ACTION
When violations are discovered, appropriate actions ranging from

issuance of a warning letter to administrative action such as compulsion to attend
seminar to imposition of fines or cancellation of product registration and/or
company license will be taken. Product recall, remedial advertising and similar
requirements may also be imposed.
Violations of P.D. 1144 and the corresponding rules and regulations shall
be governed by the penal provisions of Sec. 3, Article VIII of the FPA Rules and
Regulations No. l, Series of l977, enacted in accordance with P.D. 1144.
178
Chapter 8
MISCELLANEOUS PROVISIONS AND

REQUIREMENTS
179
Other FPA concerns that do not fit and were not covered in the previous chapters
are treated under this heading. Also, a variety of special requirements and policies that
do not clearly fit into the other categories are likely to appear from time to time. These
are included in this chapter.
8.1 STOCKS OF ANTIDOTES AND FIRST AID SUPPLIES AND EQUIPMENT FOR
CERTAIN PESTICIDES
Supplies of antidotes and/or first aid supplies and equipment necessary to

save the lives of poisoning victims are often unavailable in hospitals and rural
health centers. In order to alleviate the problem, companies distributing Toxicity
Categories I and II pesticides are required to maintain stocks of materials
recommended on the label for first aid treatment. Registrants of pesticides shall
also provide a stock of necessary emergency medicines including antidotes at
medical facilities designated by FPA. Regular quarterly inspection of these
facilities will cover this aspect. Specific conditions may form part of the
registration requirement.
8.2 INSPECTION OF BOOKS AND RECORDS
Article VI of the FPA Rules and Regulations No. 1, Series 1977 provides:
“Section I. Books and Records, Reports
A. Books and Records - The Administrator may prescribe

regulations requiring any person or handler that
manufactures, formulates, prepares, compounds, repacks
or processes any pesticide or other agricultural chemicals
to maintain books and records with respect to their
operation and the pesticide produced as determined to be
necessary for the effective enforcement of the PD 1144.
B. Reports - any person or handler, or any other person who

sells or offers for sale, delivers or offers for delivery any
pesticide or other agricultural chemical subject to PD 1144
shall, upon request of any officer or employee of the FPA,
duly designated by the Administrator, furnish reports on the
following:
1. Quantity/volume, value of each kind of pesticide or

other agricultural chemicals exported, imported,
manufactured, produced, formulated, repacked,
stored, delivered, distributed, or locally sold.
2. In case of importation, all records showing the

delivery and movement of pesticides or other
agricultural chemicals, including quantity, active
ingredients, contents, letters of credit, invoices and
180
all documents relating to the importation of such
products.
3. Other pertinent data/information that may be

required by the Authority.
Section 2. Protection of Trade Secrets and Other Information
A. In general - In submitting data required by PD 1144, the

applicant may (1) clearly mark any portion thereof which in
his opinion are trade secrets or commercial or financial
information; and (2) submit such marked material
separately from other material required to be submitted
under PD 1144.
B. Disclosure - Notwithstanding any other provision of PD

1144, the Administrator shall not make public, information
which in his judgement contains or relates to trade secrets
or commercial or financial information obtained from a
person and privileged or confidential except that, when
necessary to carry out the provision of PD 1144,
information relating to formulas of products acquired by
authorization of PD 1144 may be revealed to any
government agency consulted and may be revealed at a
public hearing or in findings of fact issued by the
Administrator.
C. Disputes - If the Administrator proposes to release for

inspection information which the applicant or registrant
believes to be protected from disclosure under subsection
(b), he shall notify the applicant or registrant, in writing, by
registered mail.
The Administrator shall not, thereafter, make available for

inspection such data until thirty (30) days after receipt of
the notice by the applicant or registrant may institute an
action in an appropriate court for a declaratory judgement
as to whether such information is subject to protection
under subsection (b).
Section 3. Inspection and Establishments
In General - For the purpose of enforcing the provisions of

PD 1144, officers or employees duly designated by the
Administrator are authorized to enter at any time, any
establishment or other place where pesticides are held for
distribution or sale, for the purpose of inspecting and obtaining
samples of any pesticide packaged, and labelled, and released for
shipment, and samples of any container or labelling for such
pesticides.
181
Before undertaking such inspection, the officers or
employees must present appropriate credentials to the owner,
operator, or any agent in charge of the establishment, or other
place where pesticides are held for distribution or sale. If the
officer or employee obtains any samples, prior to leaving the
premises, he shall give to the owner, operator, or agent in charge
a receipt describing the samples obtained and, if requested,
portion of each such sample equal in volume or weight to the
portion retained. If an analysis is made of such samples, a report
on the results of such analysis shall be furnished promptly to the
owner, operator or agent in charge.”
8.3 PROHIBITED ADVERTISING PRACTICES
Advertising shall be regulated in cooperation with the Philippine Board of

Advertising (PBA). The following are regarded as prohibited practices:
1. Advertising of pesticides as “safe”, including statements such as

“nonpoisonous, harmless, non toxic” with or without qualifying phrase
such as “when used as directed.”
2. Showing a pesticide being used with improper protective gear or with

bystanders present.
3. Including uses or other claims, which are not in the label.
4. Promoting unregistered products.
5. Advertising restricted pesticides for CPA/Institutional Use Only through

journals other than those catering for such operations, unless the
statement “Restricted Pesticide: For CPA/Institutional Use Only” is clearly
and prominently shown.
6. False or misleading comparison with other pesticides.
7. Any false statement or misleading advertising.
The pesticide industry shall also state in their advertisement: “This is an

FPA-Registered Pesticide Product, Use it strictly in accordance to its label.”
Violations of these regulations on advertising shall be sufficient cause for

imposition of a P50,000.00 fine and/or suspension/cancellation of the product’s
registration.
182
8.4 PESTICIDE PRICING POLICY
Section 6, III (8) of PD 1144 lays down the basic policy on pesticide pricing:
“Should there be any extraordinary and unreasonable increases in

prices, or a severe shortage in supply of pesticides, or imminent
dangers of either occurrences, the FPA is empowered to impose
such control as may be necessary in the public interest, including
but not limited to such restrictions and controls as the imposition
of price ceilings, controls on inventories, of such pesticides or raw
materials thereof as may be in short supply.”
8.5 TECHNICAL REVIEW/EVALUATION OF REGISTERED PRODUCTS FOR

POLICY ACTION
A point scoring system will be used in identifying/prioritizing compounds

for review. When a registered product has been identified as a cause of concern
based on reported serious damage and/or imminent hazards on public health
and environment because of its use/misuse, FPA Management shall schedule
the product for technical review for policy action. A set of primary (Table 2 or
Table 3.1 a or b) and secondary (Section 8.5.F) criteria as described herein will
be used for this purpose.
A. Preparatory Action:
1. Reasonable period of notification of product registrants of the

preliminary actions and schedule of meeting(s) with them.
2. Compilation and evaluation of the consultants’ reports on

registration evaluation and data from post-registration monitoring
activities. Data gaps shall be identified and communicated to the
concerned companies.
3. Presentation by concerned company on the latest development

and new information relevant to the requirement.
B. Industry Dialogue
1. Industry dialogue shall be conducted in a confidential manner.

Oath of confidentiality of all parties concerned shall be signed.
2. Authorized parties in the meeting are:
a. FPA Management, technical persons and secretariat.
b. PPTAC members including the registration consultants

who reviewed the product.
183
c. Registrant represented by company management and
technical persons.
3. The areas of concern of FPA shall be deliberated upon during the

meeting and the identified data gap(s) shall be requested from the
registrant. The registrants may express their reactions.
4. The PPTAC secretariat shall record and prepare the minutes of

the meeting.
5. PPTAC submits recommendation to management. FPA

Management communicates with the respective company(s) on
the areas of concern; additional data required and proposed
regulatory action. Registrant officially acknowledges receipt of
FPA communication and may request for further deliberations.
6. FPA notifies concerned companies of the schedule of further

deliberations one month in advance if necessary.
7. Whenever necessary, public hearing may be conducted to

generate more opinions as valuable inputs to policy action.
C. Decision
When all issues have been deliberated upon during the review
and dialogue, FPA Management may make a decision or refer the matter
to the FPA Board for collective deliberation and final decision.
D. Timetable
1. Management and PPTAC evaluation of areas of concern and

product review and identification of data gaps, within three (3)
months.
2. Registrant consolidation of data required for resubmission, within

three (3) months or as specified by FPA.
3. In cases where data have to be generated, the concerned

company and FPA Management shall discuss the time frame
required for the study(ies).
4. Evaluation and deliberation on data resubmitted, within three (3)

months.
E. Records
Records of all proceedings shall be kept under strict confidentiality

by the FPA Management. Only concerned companies shall be provided
with the records of the proceedings.
184
F. Parameters to be used when reviewing pesticide products for policy
action.
1. Public safety is of prime importance
a. Risk consideration to man - acute and chronic

b. Adverse effects on non-target organisms
c. Negative environmental impact
d. Pesticide residue in food
e. Disposal problem
2. Availability of suitable alternatives
a. Bio-efficacy
b. Cost effectiveness
c. Production equitability and availability
d. Ease of application
3. Special need considerations
a. Public health needs

b. Industry/end-user needs
4. Resource reconsiderations
a. Implementation
b. Manpower needs for policy action
c. Facilities
185
186
GLOSSARY OF TERMS
187
Acceptable Daily Intake (ADI) of a chemical - is the daily intake which, during an
entire lifetime, appears to be without appreciable risk to the health of the
consumer on the basis of all the known facts at the time of the evaluation
of the chemical by the joint FAO/WHO Meeting on Pesticide Residues. It
is expressed in milligrams of the chemical per kilogram of body weight.
Accredited Pesticide Dispenser (APD) - refers to the owner of the FPA licensed store
or sales person who attended a two-day training for agro-dealers and
passed the written examination.
Accredited Professional Pesticide Adviser (APPA) - refers to an individual who is a

graduate of a four-year college course or a holder of a two-year diploma
in agriculture who has undergone the training designed for such purpose
by FPA in coordination with the Weed Science Society of the Philippines
(WSSP), passed the accreditation examination, has taken an oath of
responsibility administered for such purpose and issued an FPA
accreditation card.
Accredited Responsible Care Officer (ARCO) - refers to one who is issued an

accreditation card after having attended the required training program;
passed the examination administered for the purpose; paid the required
fee and who is currently or will be proprietor/employee of agricultural
store.
Adulteration - the production of inferior products by use of less desirable ingredients.
Animal Feed - means harvested fodder crops, by-products of agricultural crops and
other products of plant or animal origin which are used for animal feeding
and which are not intended for human consumption.
Area Distributor - refers to a pesticide establishment, classified by the pesticide

companies as their distributor but with specific area of coverage and need
not register pesticide products.
Biorational Pesticides - are a distinct group, inherently different from conventional

pesticides. They comprise two major categories: (1) biochemical pest
control agents (e.g. pheromones, hormones, natural insect and plant
growth regulators and enzymes) and (2) microbial pest control agents
(e.g., microorganisms). The relationships between conventional
pesticides, biological control agents, and biorational pesticides are
illustrated in Figure 3. Pesticides to be included in these categories must
be naturally occurring, or if the chemical is synthesized by man, then it
must be structurally identical to a naturally occurring chemical. Minor
differences between the stereochemical isomer ratios (found in the
naturally occurring compound compared to the synthetic compound) will
normally not rule out a chemical from being classified as a biorational
unless an isomer is found to have toxicological properties significantly
different from those of another isomer.
188
Certified Pesticide Applicator (CPA) - refers to one who has attended a four-day
training course and passed an examination administered by the FPA.
Extraneous Residue Limit (ERL) - refers to a pesticide residue or a contaminant

arising from environmental resources (including former agricultural uses)
other than the use of a pesticide or contaminant substance directly or
indirectly on the commodity. It is the maximum concentration of a
pesticide residue or contaminant that is recommended by the Codex
Alimentarius Commission to be legally permitted or recognized as
acceptable in or on a food, agricultural commodity or animal feed. The
concentration is expressed in milligrams of pesticide residue or
contaminant per kilogram of the commodity.
Faking - unlawful manufacture of a product to misrepresent the legitimately registered

one.
Formulator - refers to one engaged in a series of operations in formulating the active

ingredient into a final product suitable for its proper application.
Good Agricultural Practice (GAP) - is the officially recommended or authorized usage

of pesticides under practical conditions at any stage of production,
storage, transport, distribution and processing of food, agricultural
commodities, and animal feed bearing in mind the variations in
requirements within and between regions, which takes into account the
minimum quantities necessary to achieve adequate control, applied in a
manner so as to leave a residue which is the smallest amount practicable
and which is toxicologically acceptable.
Household Pesticides - refer to any material or mixture of substance used for the
control of pests (e.g. flies, mosquitoes, cockroaches, ants, rodents) found
in places of human habitation, work and recreation. They shall include
pesticides used for the control of pests in homes, yards and gardens but
shall exclude chemicals used in commercial agricultural production, golf
courses, maintenance, pest extermination in industrial products and
related uses.
Importer/End-User - refers to commercial plantations which import and use the

pesticides directly and private research institutions or companies that
import or use pesticides for testing purposes.
Indentor/Trader - refers to any person/entity who acts as an agent or representative in

behalf of another or who arranges business between two or more
contracting parties.
Institution - this refers to agricultural establishments with personnel hired to do a task.

In this particular case, the task refers to the application of pesticides.
Further, the term “institution” connotes the availability of medical facilities
or arrangements for medical attention, and the assignment by the
institution or the sub-contractor of a skilled person to supervise pesticide
users.
189
Limit of Determination (LOD) - is the lowest concentration of a pesticide residue or
contaminant that can be identified and quantitatively measured in a
specified food, agricultural commodity, or animal feed with an acceptable
degree of certainty by a regulatory method of analysis.
Master Instructor-Responsible Care Officer (MI-RCO) - refers to one who has

attended the FPA-CPAP Master Instructor Course and officially can act
as resource person on specific pesticide topics.
Maximum Residue Limit (MRL) - is the maximum concentration of a pesticide residue

resulting from the use of a pesticide according to Good Agricultural
Practice that is recommended by the Codex Alimentarius Commission to
be legally permitted or recognized as acceptable in or on a food,
agricultural commodity, or animal feed, the concentration expressed in
milligrams of pesticide residue per kilogram of the commodity.
Misbranding - the illegal use of a duly registered brand name by another entity not
authorized to do so.
Pesticides for Institutional Use Only - are pesticides to be made available directly
from the Philippine distributor solely to the institution. There will be no
over-the-counter sale through the regular dealership networks.
Pesticide Company - refers to any entity/partnership corporation/cooperative/local

representative/local subsidiary who engages in the importation,
exportation, manufacture and formulation as well as supplying pesticide.
Pesticide Dealer - refers to pesticide establishments authorized by the Pesticide

Companies or Distributors to retail their products. Sale is directly to end-
users/farmers.
Pesticide Distributor - refers to one who sells pesticides to sales outlets like dealers,
traders or other distributors. It includes pesticide companies that carry
their own brand names, affix their company names in the label, reprint a
foreign company name in the country and those who were classified by
the pesticide companies as their distributors.
Pesticide Handlers - refers to exporters, importers, manufacturers, formulators,

distributors, suppliers, wholesalers, dealers, repackers, commercial
applicators, warehouse owners and retailers of agricultural and household
pesticides.
Pesticide Exporter - refers to one who exports pesticide products for commercial and
other purposes.
Pesticide Importer - refers to one who imports pesticide products for commercial and
other purposes.
190
Pesticide Manufacturer - refers to one engaged in a series of operations to obtain
active ingredient with pesticidal properties, including extraction of
pesticide active ingredients from plant materials.
Pesticide Repacker - refers to any pesticide company or its duly authorized

representative who transfer a formulation into marketable packagings.
The new packagings may carry a different brand name from the original
formulation.
Pesticide Residue - means any specified substances in food, agricultural commodities,

or animal feed resulting from the use of a pesticide. The term includes
any derivatives of a pesticide, such as conversion products, metabolites,
reaction products, and impurities considered to be of toxicological
significance.
Pesticide Supplier - refers to one who manufactures or produces pesticide outside the
country, is registered in the Republic of the Philippines, and offers
pesticides for sale to local distributors on a wholesale basis. This
application will also include all pesticide suppliers, local representatives or
suppliers’ subsidiaries/promoters.
Plant Regulators - refers to compounds other than nutrients which, in small amount,
promote, inhibit or otherwise modify any physiological process in plants.
Among the plant regulators are the growth regulators, flowering
regulators, flowering hormones, auxins and anti-auxins.
Regulatory Method of Analysis - is a method that has been validated and can be
applied using normal laboratory equipment and instrumentation to detect
and determine the concentration of a pesticide residue or contaminant in
a food, agricultural commodity or animal feed for purposes of determining
compliance with a maximum residue limit or extraneous residue limit.
Responsible Care Officer (RCO) - refers to one who had attended the required four (4)
days training program; passed the examination administered for the
purpose and is currently or will be employed as field personnel of
pesticide companies or field officers of FPA.
Surfactants - refer to surface-active agents or materials which facilitate and accentuate

emulsifying, dispensing, spreading, wetting and other surface-modifying
properties of pesticide preparations. Surfactants include but are not
limited to activators, adjuvants, deflocculators , detergents, dispersants,
drift control agents, emulsifiers, foam suppresants, spreaders, stickers,
wetting agents and others.
Synergists - refer to chemicals/materials which when combined with other chemicals

that enchance potentiation or heightens efficiency of one or more
components of the mixture such that the total effect is greater than the
sum of the independent effects of the components of the mixture. These
include, but shall not be limited to, piperonyl butoxide, propyl isomers,
sulfoxide and sesamin.
191
Wood Preservatives - refer to compounds applied or injected to prolong the service life
of structural timber as well as all wooden articles and other cellulosic
materials normally used in building construction. These include but shall
not be limited to salts of heavy metals, copper arsenates,
pentachlorophenol, creosote, dinitrophenol, sodium pentachlorophenate,
chlorinated hydrocarbon and others.
192
193
Annex I
APPENDIX A, ANNEXES 1 AND 2 OF THE

MANUAL ON THE DEVELOPMENT AND USE
OF FAO SPECIFICATIONS FOR PLANT
PROTECTION PRODUCTS, FIFTH EDITION
194
APPENDIX A
REQUIREMENTS AND PROCEDURES FOR

DEVELOPMENT OF FAO SPECIFICATIONS
Annex I: MINIMUM DATA PACKAGE
Notes:
(1) In general, studies which fulfill the requirements of modern national
registration systems will meet the needs for the development of FAO
specifications.
(2) In cases where technical material (TC) is not normally isolated, the data
and information marked with an asterisk (*) (i.e. in paragraphs 1.4, 1.5,
1.6, 1.8, 1.9, 1.10 and section 3) may be derived from the technical
concentrate (TK).
(3) The requirements of this Annex will apply in most cases. Exceptionally,
where a proposer believes that a requirement is not appropriate to the
proposed specification, or that additional information should be
considered by the Group on Specifications, the proposer must submit a
reasoned case to support this opinion. In such a case, further progress of
the proposed specification will depend on agreement (between the Group
on Specifications and the proposer) on the data required for evaluation.
(4) Data submitted will be maintained on confidential files by FAO, for future
reference as required.
1. Data Requirements for Technical Materials (TC)
1.1 Identity of the active ingredient:

ISO English common name (and its status)
Chemical name (IUPAC and CA)
CAS® No.
CIPAC No.
Structural formula
Molecular formula
Molecular mass
1.2 Physico-chemical properties of the pure active ingredient:

Vapour pressure
Melting point, boiling point or temperature of decomposition
Solubility in water
Octanol: water partition coefficient
Hydrolysis/ degradation characteristics
1.3 Outline of the manufacturing process
1.4 Minimum active ingredient content*
195
1.5 Maximum limits for the content of impurities present at or above 1 g/Kg*,
supported by batch analytical data (5 minimum). Relevant impurities (see
glossary) in this category must be identified.
Note to paragraphs 1.4 to 1.5:

The unidentified fraction of the technical material* must not
exceed 20 g/Kg.
1.6 Maximum limits for relevant impurities present at < 1 g/Kg*
1.7 Information on relevant impurities, with explanations of the effects

observed (for example, toxicological effects, or effects on the stability of
the active ingredient). Limits set by FAO/WHO Joint Meeting on Pesticide
Residues (JMPR) and/or registration authorities should accompany this
information, identifying the authority responsible for setting the limit.
Note to paragraphs 1.6 and 1.7:

Relevant impurities must be included in the specification but other
impurities (including isomers, etc., of low activity) must not be
included.
1.8 Nominal content (g/Kg) of compounds intentionally added to the technical

material* (e.g. stabilizers)
1.9 Toxicological summaries:
1.9.1 Toxicological profile of the technical material* based on acute oral,

dermal and inhalation toxicity; skin and eye irritation, skin
sensitization.
1.9.2 Toxicological profile of the technical material* based on repeated

administration (from subacute to chronic) and studies such as
reproductive and developmental toxicity, genotoxicity,
carcinogenicity, etc.
1.9.3 Ecotoxicological profile of the technical material* based on toxicity

to aquatic and terrestrial organisms (e.g. fish, Daphnia, algae,
birds, bees), as appropriate to intended use.
1.10 Other information:
1.10.1 UN International Programme on Chemical Safety (IPCS) hazard

classification.
1.10.2 References to JMPR evaluation on toxicology, environmental fate

and ecotoxicology should be given, where these exist. The
toxicological and ecotoxicological data supplied to the JMPR for
evaluation should be cross-referenced to the batch analysis data
of the technical materials used in those studies.
196
1.10.3 A letter of authorization granting competent authorities access to
registration data on behalf of FAO. This is to enable such
authorities to assess whether or not:
(i) the technical material for which an FAO specification is

proposed is equivalent to that registered by the authority,
as assessed by a comparison between the data submitted
to FAO and those submitted for registration; or
(ii) their decision that technical materials from different

manufacturers are equivalent, based on data similar to
those provided to FAO.
2. Data requirements for formulations
2.1 Main formulation types available.
2.2 Main countries where these formulations are registered and sold.
2.3 Physico-chemical properties, as required by sections 4 and 5 of this

Manual.
3. Methods for analysis and testing*
3.1 Methods for identity testing
3.2 Methods for determination of active ingredient content
3.3 Methods of analysis of impurities in the technical material*
3.4 Test methods for physico-chemical properties
Notes to section 3:
(1) The methods used to generate data submitted in fulfillment of the
requirements of paragraphs 1.4, 1.5, 1.6 and 2.3 of this Annex must also
be identified, if they differ from those given under the requirements of
section 3 and intended for checking compliance with the specification.
(2) Methods for determination of non-relevant impurities may be given in
outline but, in cases of doubt, additional information may be required to
support the validity of the method. Methods required to assess
compliance with a specification must be independently validated and
must be published or otherwise made publicly available. Where
independent validation (collaborative study of the method of analysis for
the active ingredient, or peer validation of a method for a relevant
impurity) is in progress at the date of submitting the proposal, the
estimated date of completion must be provided. Specifications will not
normally be adopted and published prior to the completion of validation of
methods and, if the validation is unlikely to be completed before the next
informal meeting of the Group, consideration of the proposal may be
deferred.
197
APPENDIX A
REQUIREMENTS AND PROCEDURES FOR

DEVELOPMENT OF FAO SPECIFICATIONS
Annex 2: PROCESS FOR DETERMINATION OF EQUIVALENCE

OF TECHNICAL MATERIALS (TC and TK)
Notes:
(1) In case where the technical material (TC) is not normally isolated, the
data and information requirements marked with an asterisk (*) may be
derived from the technical concentrate (TK). However, data submitted for
the determination of equivalence are expected to correspond to the same
form (i.e. TC or TK) of the technical active ingredient upon which the
reference specification is based.
(2) The requirements of this Annex will apply in most cases. Exceptionally,
where a proposer believes that a requirement is not appropriate to the
proposed extension of specification, or that additional information should
be considered by the Group on Specifications, the proposer must submit
a reasoned case to support this opinion. In such case, further progress of
the proposed specification will depend on agreement (between the Group
on Specifications and the proposer) on the data required for evaluation.
(3) Data submitted will be maintained on confidential files by FAO for future
reference, if required.
1. Data Requirements for the Determination of Equivalence
1.1 Data requirements for technical materials* include the information

required in paragraphs 1.1 to 1.7, 1.9.1, 1.10 and sections 2 and 3 of
Appendix A, Annex 1.
1.2 Additional toxicological summaries:
The following additional information may be required, in cases where the

equivalence cannot be determined from the data required by
paragraph 1.1
1.2.1 Toxicological profile* corresponding to that of Appendix A, Annex

1, paragraph 1.9.2
1.2.2 Ecotoxicological profile* corresponding to that of Appendix A,

Annex 1, paragraph 1.9.3.
2. Determination of Equivalence
2.1 Technical materials for different manufacturers of manufacturing

processes are deemed to be equivalent if:
198
2.1.1 The materials meet the requirements of the FAO specifications;
and
2.1.2 Assessments of the manufacturing process used and the impurity

profile (together with assessments of the toxicological/
ecotoxicological profiles, if necessary) have been carried out with
the result that the profiles meet the requirements of sections 2.3,
2.4 and 2.5 of this Annex.
2.2 Where a producer changes the manufacturing process for a technical

active ingredient which has previously been evaluated and included in the
reference specification, equivalence may be determined on the basis of
paragraphs 2.1.1 and 2.1.2 of this Annex.
2.3 Equivalence of the impurity profile of a technical material*
2.3.1 Where the maximum levels of non-relevant impurities are not

increased by more than 50% (relative to the maximum level in the
reference profile), or the absolute level is not increased by more
than 3 g/Kg (whichever represents the greater increase), and
there are no new relevant impurities, the technical materials* will
normally be considered sufficiently similar as to be equivalent.
2.3.2 Where these differences in maximum impurity concentration are

exceeded, the proposer will be asked to provide a reasoned case,
with supporting data as required, as to why these particular
impurities remain “non-relevant” and the technical material* is
equivalent. The Group on Specifications will evaluate the case to
decide whether or not the technical material is equivalent.
2.3.3 Where new impurities are present at ≥1 g/Kg, the proposer will be
asked to provide a reasoned case, with supporting data as
required, as to why these impurities are “non-relevant” and the
technical material* is equivalent. The Group on Specifications will
evaluate whether or not the technical material* is equivalent.
2.3.4 Where relevant impurities are increased in maximum

concentration, and/or where new relevant impurities are present,
additional toxicological and/or ecotoxicological data will be
required, as described in Appendix A, Annex 1, paragraphs 1.9.2
and 1.9.3
2.4 Equivalence of the toxicological profiles of a technical material*
2.4.1 The toxicological profile will be considered equivalent to that of the

reference profile, where the data required by paragraph 1.1 of this
Annex (referring to the requirements of Appendix A, Annex 1,
paragraph 1.9.1) do not differ by more than a factor of 2 compared
to the reference profile (or by a factor greater than that of the
appropriate dosage increments, if more than 2).
199
2.4.2 Where necessary (see paragraph 1.2 of this Annex), additional
toxicological data (see paragraph 1.2.1 of this Annex) will be
assessed by the criterion applied in paragraph 2.4.1. of this
Annex, provided that, where appropriate, the organs affected are
the same. The “no observable effect levels” (NOELs) or “no
observable adverse effect levels” (NOAELs) should not differ by
more than the difference in the dose levels used. There should be
no change in the assessment in those studies which produce
either positive or negative results.
2.5 Ecotoxicological profiles for the technical materials (as appropriate to the
intended use of the active ingredient)
Where required (see section 1.2 of this Annex), the ecotoxicological

profile (paragraph 1.2.2 of this Annex) will be considered equivalent to
that of the reference profile if the data do not differ by more than a factor
of 5 compared to the reference profile (or by a factor more than that of the
appropriate dosage increments, if greater than 5), when determined using
the same species.
Note to paragraph 2.3.1, 2.4.1, 2.4.2 and 2.5:

Reference profiles are defined by the information provided for the
reference specification, according to the requirements of
paragraphs 1.4, 1.5, 1.6, 1.8 and 1.9 of Annex 1, Appendix A.
2.6 Where a technical material* proposed for inclusion in an existing

specification does not comply strictly with the tests for equivalence given
in this Annex, but it is otherwise considered by the Group on
Specifications to be of acceptable or improved quality, a modification of
the existing specification will be considered, according to the procedure
outlined in Appendix A, Annex 4, Scenario 2, Case C. This procedure
may follow evaluation of the data required under paragraphs 1.1 and/ or
1.2 of this Annex.
200
Annex II
FAO SPECIFICATION
(Sample)
201
INFORMATION
COMMON NAME: Parathion (ISO)
EMPIRICAL FORMULA: C10H14NO5PS
RMM: 291.3
CAS REGISTRY NUMBER: 56-38-2
CIPAC CODE NUMBER: 10.b
CHEMICAL NAME:
0,0-diethyl 0-4-nitrophenyl phosphorothioate (IUPAC)

0,0-diethyl 0-(4-nitrophenyl) phosphorothioate (CA)
202
PARATHION TECHNICAL
FAO Specification 10.b/TC/S (1989)
1 DESCRIPTION
The material shall consist of parathion together with related manufacturing

impurities and shall be a brown liquid with a garlic-like odour free from visible
extraneous matter and added modifying agents.
2 ACTIVE INGREDIENT
2.1 Identity tests

(CIPAC 1B, 10.b/TC/(M.1)/2, p.1875 and -/(M.2)/2, p.1876) (Note 1).
Where the identity of the active ingredient is in doubt, then it shall comply
with at least one additional test.
2.2 Parathion
(CIPAC 1B, 10.b/TC/(M.1)/3, p.1875 or -/(M.2)/3, p.1877) (Note 2).
The parathion content shall be declared (not less than 950 g/kg) and,
when determined, the content obtained shall not differ from that
declared by more than +/- 20 g.
3 IMPURITIES
3.1 Water
(MT 30.1, CIPAC 1, p.897)
Maximum: 1 g/kg
4 PHYSICAL PROPERTIES
4.1 Acidity
(31.1.1, CIPAC 1, p.903)
Maximum: 3 g/kg calculated as H2S04
______________
Note 1. Alternatively, the method 10.b/1/M41.3, CIPAC 1, p.555 may be used.
Note 2. Alternatively, the method 10.b/1/M41.2, CIPAC 1, p.551 may be used.
203
PARATHION WETTABLE POWDERS
FAO Specification 10.b/WP/S (1989)
1 DESCRIPTION
The material shall consist of a homogeneous mixture of technical parathion

[complying with the requirements of FAO Specification 10.b/TC/S (1989)]
together with filler(s) and any other necessary formulants. It shall be in the form
of a fine powder free from visible extraneous matter and hard lumps.
2 ACTIVE INGREDIENT
2.1 Identity Tests

(CIPAC 1, 10.b/3/M/1.4, p.558)
Where the identity of the active ingredient is in doubt, then the isolated
active ingredient shall comply with at least one additional test.
2.2 Parathion
(CIPAC 1, 10.b/3/M/1.2, p.558)
The parathion content shall be declared (q/kg) and, when determined, the
content obtained shall not differ from that declared by more than the
following amounts:
Declared Content Permitted Tolerance
up to 100 g/kg +/- 10% of the declared content

100 to 250 g/kg +/- 6% of the declared content
250 to 400 g/kg +/- 5% of the declared content
above 400 g/kg +/- 20 g.
3.1 Acidity or alkalinity

(MT 31.1.2, CIPAC 1, p.903)
Maximum acidity: 5 g/kg calculated as H2SO4

Maximum alkalinity: 2 g/kg calculated as NaOH
3.2 Wet Sieve Test

(MT 59.3. CIPAC 1, p.981)
Maximum: 2% retained on a 75 µm test sieve
3.3 Suspensibility
(CIPAC 1, 10.b/3/M/1.6, p.559) (Notes 1 and 2)
204
A minimum of 60% of the parathion content found under .2.2 shall be in
suspension after 30 minutes in CIPAC Standard Water C. (Notes 1 and
2).
Alternatively, if the buyer requires other CIPAC Standard Waters to be

used, then this shall be specified when ordering.
3.4 Persistent foam

(MT 47, CIPAC 1, p.954) (Note 3)
Maximum: 25 ml after 1 minute.
3.5 Wetting of the product

(MT 53.3.1, CIPAC 1, p.967)
The product shall be completely wetted in 1 minute without swirling.
4 STORAGE STABILITY
4.1 Stability at 54°C

(MT 46.1.1, CIPAC 1, p.951)
After storage at 54 +/- 2°C for 14 days, the product shall continue to
comply with .2.2, .3.1, .3.2 and .3.5.
____________________
Note 1. The product should be tested at the highest and lowest rates of use
recommended by the supplier, provided this does not exceed the conditions
given in the method MT 15.1, CIPAC 1, p.861.
Note 2. This test will normally only be carried out after the heat stability test .4.1.
Note 3. The amount of sample to be used in the test should be specified.
205
PARATHION EMULSIFIABLE CONCENTRATES
FAO Specification 10.b/EC/S (1989)
1 DESCRIPTION
The material shall consist of technical parathion [complying with the requirements
of FAO Specification 10.b/TC/S (1989)] dissolved in suitable solvents with any
other necessary formulants. It shall be in the form of a stable liquid, free from
visible suspended matter and sediment.
2 ACTIVE INGREDIENT
2.1 Identity tests

(CIPAC 1B, 10.b/EC/(M.1)/2, P. 1878 and -/(M.2)/2, P. 1878) (Note 1)
Where the identity of the active ingredient is in doubt, then the isolated
active ingredient shall comply with at least one additional test.
2.2 Parathion
(CIPAC 1B, 10.b/EC/(M.1)/3, p.1878 o -/(M.2)/3, P. 1878 (Note 2)
The parathion content shall be declared (g/kg or g/1 at 20°C, (Note 3) and
when determined, the content obtained shall not differ from that declared
by more than the following amounts:
Declared content Permitted tolerance

up to 500 g/kg or g/l +/- 5% of the declared content
above 500 g/kg or g/l +/- 25 g.
3 IMPURITIES
3.1 Water
(MT 30.1, CIPAC 1, p.897 or MT 30.2, p.899)
Maximum: 2 g/kg
4.1 Acidity or Alkalinity

(MT 31.1.3, CIPAC 1, p.904 or 31.2.3, p.905)
Maximum acidity: 3 g/kg calculated as H2SO4

Maximum alkalinity: 1 g/kg calculated as NaOH
4.2 Emulsion stability and re-emulsification

(MT 36.1.1, CIPAC 1, p. 910)
After the heat stability test (5.2), the product, when diluted at 30°C, (Note
4) with CIPAC Standard Waters A and C, shall comply with the following:
206
Time after dilution Limits of stability
0h Initial emulsification complete

0.5 h 'Cream', maximum: 2 ml
2.0 h 'Cream', maximum: 4 ml
‘Free oil', nil
24 h (Note 5) Re-emulsification complete
24.5 h (Note 5) ‘Cream', max: 4 ml
‘Free oil’, max: 0.5 ml
In special cases, a test using CIPAC Standard Waters A and C before the
heat stability test may be necessary.
Alternatively, if the buyer requires other CIPAC Standard waters to be

used, then this shall be specified when ordering.
4.3 Flash point

(MT 12, CIPAC 1, p.846)
If required, the flash point of the product shall not be lower than the
minimum declared flash point. A closed cup method shall be used and the
method stated (Note 6).
5 STORAGE STABILITY
5.1 Stability at O°C

(MT 39.1, CIPAC 1, p.930)
After storage at 0 +/- 1°C for 7 days, the volume of solid and/or liquid
which separates shall not be more than 0.3 ml.
5.2 Stability at 54°C

(MT 46.1.3, CIPAC 1, p.952)
After storage at 54 +/- 2°C for 14 days, the product shall continue to
comply with 2.2 and 4.1
___________________
Note 1. Alternatively, the method 10.b/5/M/l.4, CIPAC l, p.565 may be used.
Note 2. Alternatively, the method 10.b/5/M/1.3, CIPAC 1, p.563 may be used.
Note 3. If the buyer requires both g/kg and g/l at 20°C, then in case of dispute, the analytical
result shall be calculated as g/kg.
Note 4. Unless another temperature is specified.
Note 5. These tests need only be carried out in case of doubt as to the emulsion stability result
of the 2 hour test.
Note 6. Attention is drawn to the appropriate national international regulations on handling and
transport flammable materials.
207
Annex III
FPA BIOEFFICACY PROTOCOL
208
BIOLOGICAL EFFICACY TEST PROTOCOLS
I. INTRODUCTION
Adequate data to support claims on the label for effectiveness of a

pesticide against selected pest species should be provided by the registrant as
an integral part of registration. Such efficacy data should comply with the basic
requirements specified in these guidelines and should be generated from field
trials under practical conditions of use. The trials should be conducted in
accordance with the test protocols prescribed herein.
Although it is preferred that efficacy trials be conducted in the Philippines,

relevant data from other countries with similar climatic and pest conditions shall
be accepted for registration purposes, provided these data are obtained following
FPA prescribed test protocols. Moreover, company in-house data will be
accepted as supporting documents only and cannot be used as primary basis for
registration.
The prescribed test protocols are designed to facilitate transportability of

efficacy data and to provide a uniform, simplified format with built-in advantages
in record keeping, reporting of results and evaluation of data. These bioefficacy
test protocols are intended as guide to researchers and registrants and
adherence should be to the principles of validity, randomness and lack of
experimental bias rather than to any rigid set of requirements. Under complex
situations and justifiable circumstances, procedural changes may be considered
by FPA.
The specific protocols outlined herein cover trials on rice, corn, vegetables, turf,
and plantation crops, such as banana and pineapple. A general requirement for
household bioefficacy trials is also included. These are designed for FPA
registration purposes. Efficacy data obtained from test protocols for other crops
not included in these guidelines shall be accepted provided that these were
granted EUP following the official procedures prescribed by FPA.
II. GENERAL REQUIREMENTS
A. Experimental designs (any of the following depending on objectives)
1. Randomized Complete Block Design (RCBD)

2. Latin Square (LS)
3. Split-plot design
4. Factorial (for rodenticides)
B. Experimental data not older than three (3) years.
C. Statistical analysis and appropriate tests of means.
209
D. Data should be generated from at least two (2) season trials, preferably wet,
for rice and corn, two (2) regular cropping seasons for all other crops and in
exceptional cases, same season but from two (2) locations with different
climatic conditions.
E. Additional information – amount (Kg a.i. per hectare) and timing of application
of standard pesticides.
F. For granular formulation or sprayables to be applied as soil surface

treatment, assessment of soil fauna before and after treatment is a must.
G. Effects on beneficials (pollinators and natural enemies) and other non-target

species should always form part of the data to be generated.
H. Adequate infestation level as indicated by population or damage level in the

unprotected control plots.
I. For vegetables and other upland crops, a bigger plot size is recommended (at
least 40 m2). Lowland rice experiments can be done at a minimum lot size of
20 m2 per plot per treatment. Minimum number of replication should be at
least three (3) replicates.
J. Phytotoxicity evaluation should be done following crop injury rating for

herbicide on V.B.2.
III. REQUIREMENTS FOR SPECIFIC CROPS
Specific Requirements for Rice
A. Insecticides
1. Number of Trials
a. Number of Seasons 1 preferably wet
b. Number of Location 2 different climatic conditions
c. Number of Replication 3 (preferably 4 to have a fall back
set)
2. Experimental Design RCBD or LS as appropriate
3. Plot Size Minimum of 20 m2 (4m x 5m)
4. Adequate Infestation Level Adequate insect infestation of at

least 10%. Artificial infestation may
be introduced when necessary.
5. Reference Plot a. Untreated control plots

b. Reference treatment, currently
registered similar product
210
6. Method of Assessment
a. Phytotoxicity assessment to be taken 3 to7 days after treatment

following the crop injury rating scale for herbicide (V.B.2).
b. Bioefficacy Assessment
The primary basis of effectiveness should be population count

before and after treatment. In cases where population is difficult to
take, damage rating may be used to measure treatment effects but
has to be done at appropriate time to really measure the effects of the
treatments. Post treatment counts should be based on company
recommended re-entry period after treatment.
b.1. Rice Whorl Maggot
Get percent leaf damage per hill based on the two (2)
youngest leaves per plant. Data should be taken from at least 20
sample plants per plot or treatment and replicated at least 3
times.
b.2. Green Leafhoppers
b.2.1. Actual counts before and after treatment
- Net sweep for adults covering the front 180 degrees

of the operator. Then count the number per 10-20
sweeps in each plot.
- Tap the tillers over a pan with water to collect the
nymphs and counting the actual number.
b.2.2. Estimating virus infection
- Sample at least 9 m2 (3m x 3m) quadrat and count

the infected hills.
- Compute for percent virus infected plants per plot
using the following formula:
no. of infected hills per quadrat

% virus infection = ------------------------------------------- x 100
total no. of hills per quadrat
b.3. Brown Planthopper
b.3.1. Do actual counts before and after treatment or do sweep

net sampling as indicated for GLH.
- Compute for percent virus infected plants per plot

following the formula for GLH.
211
b.4. Stemborer
b.4.1. Actual Population Counts
- This is relatively difficult to do but can be done

through destructive sampling of plants within the
plots. Take at least 20 tillers per plot per replication.
Dissect and count the number of larva present per
infested tiller. Estimate of damage is the more
convenient measure of bioefficacy.
b.4.2. Estimate of Damage
- Estimate percent damage in the middle of a 9-m²

sample area using the formula:
no. of damaged tiller or panicles

% damage = ---------------------------------------------- x 100
no. of sampled tillers or panicles
- Deadheart is assessed twice at 35 and 50 days after

transplanting (Growth stage 2) while whiteheads at
about 10 days before harvest (Growth stage 9).
b.5. Leaf Folder
b.5.1. Actual Population Counts
- Sample and open 50 folded leaves within the 9-m²

quadrat and record the number of larva present.
Counting should be done at vegetative stage
(maximum tillering) and flag leaf stages when leaf
folders are generally abundant in the field.
b.5.2 Estimate of Damage
no. of hills w/ leaf folder

damaged tillers
% Leaf folder damage = ------------------------------------ x 100
(hills or tillers) total no. of hills
b.6. Rice Caseworm
- Do actual counts of larva in 10 plants per plot 1 day before

and 3-7 days after treatment. Sample at least 20 plants per
plot.
- Count the number of damaged hills and based on the actual
number of hills, compute the percent damage.
c. Yield assessment the same as in herbicide for rice (III.C.6.d)
212
B. Fungicides
1. Number of Trials
b. Number of Location 2 different climatic conditions
c. Number of Replication 3-4
2. Experimental Design RCBD, split plot
4. Adequate Infestation Level Natural disease infection of at least

10% at the control plot.
b. Reference treatments:
Currently registered products
against the specific disease to
be tested; e.g. Benomyl for rice
blast; Iprodione for sheath blight,
etc.
a. Phytotoxicity, assessment to be taken 10-15 days after treatment

following crop injury rating scale for herbicide (V.B.2).
b.1. Rice blast
b.1.1. Foliar. Take 20 sample hills from 5 center rows

randomly taken and determine average % leaf area
infected following the rating scale (V.A.1.a).
b.1.2. Neck and Node. Take 20 sample hills from 5 center rows
at random and determine % infected plant (V.A.1.b).
b.2. Sheath blight
Take 20 sample hills from 5 center rows at random and

determine the average sheath and leaf infection following the
rating scale (V.A.2).
b.3. Sheath rot

determine the average infected tillers following the rating scale
(V.A.3).
213
b.4. Cercospora and Helminthosporium Spot

determine the average % leaf area infected following the rating
scale (V.A.4).
c. Reading to be taken twice during growth stage indicated in the rating

scale (Appended).
d. Yield assessment the same as in herbicide for rice.
C. Herbicides
1. Number of Trials
a. Number of Seasons 2 (1 wet and 1 dry)
For rice grown only in one season,
e.g. in Kabsaka - 1 season
b. Number of Location 3 different geographic areas (with
different climatic conditions)
c. Number of Replication 4
2. Experimental Design RCBD or split plot
4. Adequate Infestation Level Natural weed infestation of at least

25% ground cover in the unweeded
plot at 15-40 days after transplanting
(DAT) or after direct seeding.
5. Reference Plot a. Control plots

1. Unweeded control
2. Handweeded control, 2-3x
within 40 DAT (not applicable
on direct seeded rice) or
weed-free control (4-5x
handweeding)
For Grasses - Butachlor,
Thiobencarb, 2,4-D (pre-
emergence), Oxadiazon,
and/or any currently
registered similar herbicides
Broadleaves - 2,4-D (post-
emergence) and/or any
currently registered similar
herbicides
Mixed Populations of annual
grasses, broadleaves,
214
sedges - Butachlor + 2,4-D or
any currently registered
similar herbicides.
a. Crop injury and weed control rating by species to be taken 1-3 weeks
after treatment using the rating scale (V.B.2 and V.B.1).
b. Weed count and weed weight by species 40 days after

transplanting/direct seeding taken once per plot. Use a 50 cm x 50 cm
quadrat per plot.
c. Take 5 hills sample per plot at 45 days after transplanting/direct

seeding and count the number of tillers.
d. Grain yield. For transplanted rice sample 5 center rows in the plot. For
direct seeded sample 3 m x 4 m center area in the plot. Express yield
in Kg/ha.
Specific Requirements for Corn
A. Insecticides
1. Number of Trials
b. Number of Location 2 different climatic regions/areas
c. Number of Replication Minimum of 3 (preferably 4)
2. Experimental Design RCBD or LS
3. Plot Size 30 m2 (3m x 10m)
4. Adequate Infestation Level At least 10% infestation in the

unprotected control plot.

b. Positive control – use any
insecticides.
a. Phytotoxicity rating following crop injury rating for herbicides (V.B.2).
b.1. Corn Seedling Maggots
215
Sample 9-m2 quadrat per replication. Count the damaged
seedlings (indicated by deadhearts) and compute for percentage
damaged seedlings at 1-2 weeks after emergence.
b.2. Corn Earworm
Assess damage at late silking stage (before and after

treatment) by taking the number of damaged ears.
No. of damaged ears

% damaged ear = ----------------------------------- x 100
total no. of ears sampled
For actual counts, examine at least 20 ears and count

number of larva.
Actual corn earworm count is expressed in terms of average

number of worms per plot per replication.
b.3. Corn Borers
Corn borer counts maybe done at least twice and a final

damage assessment after harvest.
First count is recommended at whorl stage. Count larva in at

least 20 sample plants before and after treatment (closest to
whorl stage). Second counting can be done at application
closest to tasselling stage. Randomly sample (destructive
sampling) 20 tassels per treatment and examine for presence of
corn borer larva.
Final damage rating is done by measuring the borer larval

tunnels by splicing the stalks (at least 10 sample plants per
treatment per replication) and counting and measuring the
tunnels within the plant. Express data in terms of mean number
of larval tunnels per plant and mean length (cm) of tunnels.
c. Yield Assessment
Take yield of the whole plant and express yield in terms of Kg/ha
(grain or green corn). For green corn, numbers of marketable and
non-marketable ears should be reflected as final bioefficacy
parameter.
B. Fungicides
1. Number of Trials
b. Number of Location 2
c. Number of Replication 3-4
216
3. Plot Size 30 m2

10% at the untreated control. Point
source inoculations if necessary.

Seed dressing - Metalaxyl for
downy mildew, TMTD as general
seed protectant
a. Phytotoxicity rating following the crop injury rating for herbicides

(V.B.2).
Sample plants per plot for observation should not be less than 30.
b.1. Downy Mildew
Take the percentage of infected plants or disease incidence

(V.A.5b). Number of infected plants divided by total number of
samples x 100.
b.2. Other fungal diseases (leaf spots, rusts, blights)
Take the percent leaf area following the rating scale (V.A.5a)
and compute for % disease severity using formula V.A.1a.
c. Get the actual yield from the whole plot converted to Kg/ha.
C. Herbicides
1. Number of Trials
a. Number of Seasons 2 (wet and dry)
b. Number of Location 2 different climatic areas/regions
3. Plot Size 30 m2
217
plot at 15-40 days after planting.

1. Unweeded control
within 40 days after planting
or weed-free control (4-5x
handweeding)
For annual grasses &
broadleaves (Excluding
Rottbellia) - Atrazine and/or
similar herbicides
For broadleaves & sedges -
MCPA, 2,4-D (post-
herbicides
For annual grasses including
Aguingay (Rottboellia) -
Pendimethalin (pre-
herbicides
a. Take weed control rating by species and crop injury rating 1-3 weeks
after herbicides treatment using the rating scale (V.B.1 and V.B.2).
b. Take weed counts and weed weights by species from 50 cm x 50 cm
quadrat per plot at 4-6 weeks after planting.
c. Take the yield from the whole plot (excluding area sampled for weeds)
transformed to Kg/Ha.
Specific Requirements for Vegetables
A. Insecticide
1. Crucifers - Pechay and Cabbage
In general, insect pests seriously damaging crucifers are mostly under

the lepidoptera group (cutworm and diamond back moth) and
occasionally cabbage worm. These insects are also observed throughout
the growing stage.
218
Plot size should be at least 40 m2 (8m x 5m). Sampling should be
within the middle row plants to prevent border effects (drift from adjacent
treatments). If trials are done in farmer’s field where strips are narrow,
efforts should be done to prevent treatment drift by deliberate use of
barriers like plywood or sackcloth during actual spraying.
Insect counts (pests and beneficial organisms) are done 1 day before
and 3-5 days after treatment (based on company suggested re-entry
period).
Harvest data should include weight or number of marketable and non-

marketable product.
2. For Legumes (particularly aphids, leafhoppers, thrips, mites and pod

borers)
Arthropod monitoring should be done a day before and 3 days after

spraying at a time not later than 10:00 in the morning or not earlier than
4:00 in the afternoon, in all plots, including even the untreated ones.
Determine the extent of beanfly infestation by dissecting 20 plants per

plot at 21 days after emergence and counting the number of larvae and
pupae. In case the actual counts before and after treatment is desired,
sample 20 seedlings before and after treatment and dissect the plants.
Record the actual larval/pupal counts.
The number of leafhopper, thrips and mites should be determined

from 3 selected trifoliate leaves, representing the upper, middle and lower
foliage of 5 sample plants per plot.
The number of leaves per canopy level of each of the 5 randomly

selected plants per treatment should be noted at each monitoring date.
Count the number of aphid colonies in 3 youngest trifoliate leaves of a

stalk of 10 plant sample in a plot. Bioefficacy is expressed in terms of
mean number of aphid colonies per plant as well as % aphid infested
plants. Determine the infestation level using the following formula:
Total no. of infested plants

% Infestation = ------------------------------------- x 100
Total number of plants
Observe the five youngest trifoliate leaves per 20 sample plants per
plot for larvae and pupae of leafminers during the regular arthropod
monitoring schedule.
Finally, for pod borer evaluation, at least 3 sampling dates are

required (at flowering stage, at 2nd and 4th priming). Note that ideally,
insect counts should be done before and after treatment. However, these
219
may build-up so much data that may lead to difficulty in analysis. Thus, a
minimum of 3 assessments for pod borer is acceptable. It is important
that the level of infestation in the unprotected control set is relatively high.
Since leafhoppers and thrips can be very damaging at earlier crop stage,
it is recommended that protection against these insects be done before
the onset of flowering but without effects on the pod borer population.
Sample 50 flowers within the plot and dissect to count the number of
pod borer larva. For the pod borers on pods, take the harvest from 50
plants within the middle 2 rows, weigh and count the number of
undamaged and damaged pods. Compute for percent damaged pods.
Assess level of pod infestation by taking at least 20 damaged pods and
split to expose the seeds and count the number of larva present in the
pod. Compute for mean number of larva per pod.
3. Eggplants (particularly aphids, leafhoppers, leafminers and shoot and fruit
borers)
Arthropod monitoring should be done a day before and 3 days after

spraying at a time not later than 10:00 in the morning and not earlier than
4:00 in the afternoon, in all plots, including the untreated ones.
Determine the number of leafhopper, thrips and mites from 3

randomly selected leaves, representing the upper, middle and lower
foliage of 10 sample plants per plot. Use the same number and site of
leaves in assessing aphid infestation. The aphid units should be
expressed in colonies per plant. Determine percent infestation using the
following formula:
Total no. of infested plants
% Infestation = ------------------------------------- x 100
Total no. of plants
The number of insects (colonies for aphids, actual number for thrips
and mites) per plant of 5 randomly selected plants per treatment should
be recorded at each monitoring data.
Damage assessment for leaf hopper is at least once (when damage

difference among treatments is obvious) done by visual rating of the plot
using the following rating scale:
SCALE DESCRIPTION
1 No damage or only few lower leaves turning yellow
due to leafhopper feeding
3 About 25% of mature leaves turning yellow
10 All leaves yellowing and cupping due to leafhopper
damage
220
Assessment for shoot and fruit borer can be done at late vegetative
stage (35-45 DAT), while percentage damaged fruits can be taken every
after priming or harvest. The damage ratings should be supported by
actual population count by dissecting damaged fruits during harvest at
least three times.
B. Fungicides
1. Number of Trials
3. Plot Size 5-10 m2 for non-vine crops

15 m2 for vine crops
30 m2 for green corn

10% at the untreated control. Point
source inoculations if necessary.

For late blight on white potato &
tomato - Chlorothalonil
registered similar fungicides
For downy mildew of cucurbits -
Mancozeb, Metalaxyl and/or
similar fungicides
For anthracnose of beans and
pepper - Mancozeb, Benomyl
For leaf mold of tomato and okra
- Mancozeb, Benomyl and/or
similar fungicides
For downy mildew of
green/sweet corn - Metalaxyl
For root knot nematodes -
Carbofuran and/or any
fungicides
221
a. Phytotoxicity rating following the crop injury rating for herbicides

(V.B.2).
b. Percent infected plants and percent leaf area taken from no less than
20 randomly collected plants per plot following rating scale (V.A.5b
and V.A.5a).
c. For nematodes, take the percentage of total root system galled and
transform to rating scale (V.A.6).
d. Take the yield from whole plot and transform to Kg/Ha.
C. Herbicides
1. Number of Trials
a. Number of Seasons 2 (wet and dry)
b. Number of Location 2 different geographic areas with
different climatic conditions
3. Plot Size 20 m2 (4m x 5m)

30 m2 for green corn

plot at 15 days after
planting/transplanting.
5. Reference Plot a. Control plots:

1. Unweeded control
before close-in time or weed-
free control (4-5x
handweeding)
For annual grasses (except
Rottbellia) and broadleaves-
Atrazine (pre-emergence)
for green corn
For annual grasses including
Rottbellia - Pendimethalin as
pre-emergence and/or any
222
herbicides for green corn
For broadleaves & sedges -
MCPA, 2,4-D (post-
emergence) applied at 15-20
days after transplanting
for green corn
Broad spectrum - Oxyfluorfen
applied 7 days after
transplanting and/or any
herbicides for onion
a. Crop injury and weed control assessment taken 1-3 weeks after
herbicide application transformed to the rating scale (V.B.2 and
V.B.1).
b. Weed counts and weed biomass by species using a 50 cm x 50 cm
quadrat at 30 to 45 days after planting or transplanting.
c. Take the yield from the whole plot excluding sample area transformed
to Kg/Ha.
Specific Requirements for Other Crops
A. Insecticide (Banana and Pineapple)

The most common problem in banana is the flower thrips while mealybug
appears to be significant in pineapple because of its being the vector of pink
disease in pineapple.
For systematic comparison of treatments, an unprotected control should
be the reference point (not only to establish comparative advantage but also
to provide idea of the level of pest pressure). In cases however that an
unprotected plot becomes a threat to the bigger field (due to pest migration),
this requirement may be waived provided that counts or damage
assessments (as may be applicable) are done before and after treatment.
1. Banana – for the banana flower thrips
If an unprotected plot is not possible, a pre treatment count for all

treatments will suffice. For injectibles, post treatment can be done at 5
days after injection when dead thrips are expected to be highest. For
economic reasons, at least 3 buds per treatment per replication (hence a
total of 9 buds per treatment) should be sacrificed (split into half and
observed for actual dead or alive thrips).
223
Final assessment of thrips damage is done at harvest on hands using
the water soaked or corky scab damage as indicator of the level of
protection accorded by the product against the thrips.
2. Pineapple Mealybugs
Just like in banana plantations, unprotected control plot requirement

may be waived provided a pre treatment count is made to establish pest
pressure prior to treatment. Efficacy is assessed based on actual counts
after treatment expressed in terms of % mortality or % population
reduction vis-à-vis the standard plantation practice. Minimum plot size
should be not less than 500 m2 per treatment and replicated at least 3
times.
B. Herbicides for turf/perennial crops (rubber, banana, pineapple)
1. Number of Trials
a. Number of Seasons 2
2. Experimental Design RCBD
3. Plot Size at least 4m x 5m
4. Adequate Infestation Level at least 25% ground cover in the

unweeded plot at 15-40 days after
planting.

1. Unweeded control
2. Handweeded (2-3x) or weed-
free control (4-5x)
Grasses: posterm grass
herbicides (Fluazipop,
Cyhalopop) or currently
recommended herbicides.
Broadleaf weeds and sedges:
2,4 – D, Bensulfuron, or
currently recommended
herbicides.
Mixture: Glyphosate,
Glufosinate, Sulfonylurea or
other currently recommended
herbicides.
224
a. Same as in corn/vegetables.
b. No. of days to 30 % weed regrowth.
c. Yield or other yield parameters from 10 m2 area or whole plots,

expressed in Kg/ha.
IV. Specific Requirements for Rodenticide Trials
A. Rodenticide Trial - Field
1. Number of Trials

b. Number of Location 2 in areas with at least moderate rat
population
c. Number of Replication 3; treated and check plots should be
separated at least by 300 m.
2. Experimental Design t-test, DMRT or other applicable

statistical analysis
3. Plot Size Minimum of one (1) hectare/

replication/treatment.
Plots should be at least 300 m apart.
4. Adequate Infestation Level Average of 5-10% rat activity (from a

3-day data)
5. Reference Plot Untreated plot – (but sometimes

farmers may use same rat control
procedure, so this should be noted).
6. Method of Assessment Preferably a periodic assessment of

rat damage and supplemented by
activity tiles.
a. Pre-treatment 4 WAT preferably 2 WAT for rice; or

at least 1 month for corn; or 3-4
months after planting/ratoon crop
(for sugarcane).
225
b. Periodic assessment on the performance of the treatments at these
following stages of the crop:
Rice Corn Sugarcane
1st pre 2–4 4 Weeks After 3 months Ratoon

treatment WAT Seeding (WAS) 4-5 months new
planting
Periodic: 8, 12 8, 12 WAS Every month
WAT thereafter
Before 2 weeks 1-2 weeks Assess damage on
harvest harvested canes
c. Assess bait consumption - 2 days after baiting

- periodically as long as baiting is
going on
d. Take note of possible risks to - Interview people in community to

non-target animals find out if there are animals that
were affected.
- Review records of local/municipal
health centers/hospitals on
poisoning cases.
e. Yield loss Base it on yield without rat damage.
f. Cost/benefit analysis (optional) Use partial budgeting.
B. Rodenticide – animal farm and establishments (buildings, hotels,

supermarkets and houses)
1. Number of Trials
a. Number of Seasons 1
b. Number of Location 2 in areas with at least moderate rat
infestation
c. Number of Replication Minimum of 2; preferably 3
2. Treatments Treated vs. untreated
3. Experimental Design A t-test may be sufficient
4. Adequate Population Pressure a. Based on damaged structures,

food, eggs (in poultry houses,
etc.)
b. Based on activity data ≥ 5% rat

activity
226
5. Reference Plot Untreated establishment/house
a. Pre-treatment - Take note of damaged counts, e.g.

no. of eggs broken, chicks killed by
rats
- Average of 3-day rat activity data
b. During treatment The same as #a
c. Post treatment The same as #a
7. Efficacy Results
a. Reduced number of damaged counts, e.g. broken eggs, etc.

compared to the pretreatment assessment.
b. Clients’ feedback
V. Standard Rating Scales for Evaluation of Pest Damage
The currently differing rating scales adopted by researchers and research

agencies in assessing pest damage have created difficulties in evaluating and
comparing data sets. Thus, this standard rating scale system is addressed to
answer the problem. The system uses a six or five-digit scale to facilitate rapid
interpretation of scores to provide more intermediate scores and to discriminate
treatment effects more readily.
A. Diseases
A.1. Rice Blast
A.1.a. Foliar blast
SCALE DESCRIPTION
0 No lesion/infection
1 Small to larger brown specks, infecting 1-5 % of leaf
area
3 Typical blast lesions, infecting 6-15 % of leaf area
9 More than 50 % leaf area affected
Reading should be taken at growth stage 3 to 5.
Compute % disease severity using the formula:
227
n(0) + n(1)…+ n(9)
% D.S. = ------------------------------------------ x 100
Nx9
Where: n = number of infested plants classified by

grade (scale)
N = total number of samples
A.1.b. Neck and Node blast – use actual count of infected plants and
convert to % disease incidence (number of infected plants
divided by total number of samples x 100).
Reading should be taken at growth 7-9.
A.2. Sheath Blight
SCALE DESCRIPTION
0 No incidence.
1 Lesion limited to lower than 20 % of the plant
height.
3 Lesion limited to 20 – 30 % of the plant height.
9 Lesion limited to more than 65 % of the plant height.
Reading should be taken at growth stage 5-9.

A.3. Sheath Rot
SCALE % INFECTED TILLERS

0 No incidence
1 Less than 1 %
3 1–5%
5 6 – 25 %
7 26 – 50 %
9 51 – 100 %
Reading should be taken at growth stage 7-9.
A.4. Helminthosporium and Cercospora Leaf Spot (at growth stage 5 – 9)
SCALE % LEAF AREA INFECTED

0 No incidence
1 Less than 1 %
3 1–5%
5 6 – 25 %
7 26 – 50 %
9 More than 50 %
A.5. Diseases of Vegetables
228
A.5a. Rating Scale for diseases exhibiting localized symptom (leaf
spots, blight, anthracnose, etc.)
SCALE % AREA INFECTED

0 None
1 1–5%
3 6 – 12 %
5 13 – 25 %
7 26 – 50 %
9 More than 50 %
Reading should be taken at least 15 days after inoculation.
A.5b. Rating scale for diseases exhibiting systemic symptoms (wilts

and rots and downy mildew of corn).
Use actual count of infected plants and convert to % disease

incidence.
A.6. Nematode Root Gall Scale
SCALE % OF TOTAL ROOT SYSTEM GALLED

0 No gall
1 Less than 1
3 1 – 10
5 11 – 30
7 31 – 60
9 61 and above
B. Weeds
B.1. Weed Control Rating
SCALE % WEED CONTROL BASED ON THE

UNTREATED CHECK
1 91- 100
3 81 – 90
5 71 – 80
7 61 – 70
9 60 & below
B.2. Crop Injury Rating
SCALE % CROP INJURY BASED ON THE

UNTREATED CHECK
1 None
3 1 – 10
5 11 – 20
7 21 – 30
9 > 30
229
C. Rat Damage
SCALE % DAMAGE PLANTS (HILL)

1 0 – 10
3 11 – 15
5 16 – 20
7 21 – 25
9 25 & above
VI. General Requirement for Household Bioefficacy Trials
Bioefficacy evaluation against common household pests like houseflies

and cockroaches should be made using uniform laboratory reared insects. In
case of field evaluation, every effort should be done to determine the level of pest
before treatment application. Effect of treatments is based on per cent mortality
(or moribund insects) after treatment. It is very important that positive (standard
commonly used product) and negative controls (unprotected or blank solution)
are included in the test.
For aerosols, the effect of the carrier should also be assessed (and
should be used as the negative control set).
Foreign data maybe considered provided these are conducted in places

with similar environmental/climatic conditions as the Philippines and against our
specific species. In-house company data will be accepted as supporting data but
not as sole basis of registration. The format of data presentation should also
follow FPA required format.
230
APPENDIX I
GROWTH STAGES OF RICE PLANTS
Code Description
0 Germination to emergence
1 Seedling or transplanting
2 Tillering
3 Stem elongation
4 Booting (beginning with panicle initiation)
5 Heading
6 Flowering
7 Milk stage
8 Dough stage
9 Mature grain
231
Annex IV
LABELLING GUIDE
232
233
234
235
Annex V
LABELLING OF HOUSEHOLD PESTICIDES
236
BRAND OR TRADE NAME
Composition: Active Ingredient(s) (%)

Solvent
Inert Ingredients (%)
Total
CAUTION All capitals and bold face, at least

¼ type size of the brand name
KEEP OUT OF REACH OF CHILDREN
FOR SURFACE SPRAY
Manufactured by:
COMPANY
ADDRESS
FPA Registration No. ________ Net Content ______ g/L
DIRECTIONS FOR USE

Use only as surface spray. Point valve opening towards cracks and crevices
and other surfaces to be sprayed and press button firmly until surfaces are
moist. Safe entry into treated areas – after surfaces are dry pr 30 minutes has
lapsed from application time.
PHYSICAL/CHEMICAL HAZARDS
Flammable. Contents under pressure. Keep away from heat, sparks,
and open flame. Do not puncture or burn container.
STORAGE AND DISPOSAL

Storage: Store in cool area away from heat or open flame.
Disposal: Do not re-use empty container.
HOUSEHOLD PESTICDE LABEL (FRONT)
237
PRECAUTIONS
(all capitals and bold face, at least ¼ type size of brand name)
HAZARDS TO HUMANS AND DOMESTIC ANIMALS

Harmful if swallowed, inhaled, or absorbed through the skin. Do not spray directly
on animals. Do not contaminate foodstuffs, dishes, and utensils. After use, wash
hands thoroughly. Do not enter treated areas until surfaces are dry. Provide
adequate ventilation on area.
FIRST AID TREATMENT
If inhaled: Remove victim from area of exposure and bring to fresh air.
If swallowed: For Liquid Formulation

If a solvent is a hydrocarbon – kerosene, xylene and other petroleum
distillates. DO NOT INDUCE VOMITING.
If a solvent is not a hydrocarbon: Drink 1-2 glasses of water and

induce vomiting by touching the back of throat with a finger or blunt
instrument.
If in eyes: Flush eyes with running water. Get medical attention immediately
If on skin: Remove contaminated clothing and wash affected areas with plain
soap and water
NOTE TO PHYSICIAN
Antidote: Contains (DDVP, Propoxur) a cholinesterase inhibitor. Give atropine

sulfate as antidote. Maintain patent airway and vital signs. If with
pyrethroids, avoid adrenalin-type drugs.
FORMULATION DATE: Month and Year

BATCH NUMBER:
HOUSEHOLD PESTICDE LABEL (BACK)
238
Annex VI
GUIDELINES ON GOOD LABORATORY

PRACTICE IN PESTICIDE RESIDUE ANALYSIS
239
GUIDELINES ON GOOD LABORATORY PRACTICE
IN PESTICIDE RESIDUE ANALYSIS1
1. INTRODUCTION
The ultimate goal in fair practice in international trade depends, among other
things, on the reliability of analytical results. This, in turn, particularly in pesticide residue
analysis, depends not only on the availability of reliable analytical methods, but also on
the experience of the analyst and on the maintenance of "good laboratory practice in the
analysis of pesticides". These guidelines define such good analytical practice and may
be considered in three inter-related parts:
The Analyst;
Basic Resources; and
The Analysis.
A discussion of each of these follows:
2. THE ANALYST
2.1 Residue analysis consists of a chain of procedures, most of which are known, or
readily understood, by a trained chemist, but because the analyte concentrations
are in the range mg/kg to Tg/kg, attention to detail is essential. The analyst in
charge should have an appropriate professional qualification and be experienced
and competent in residue analysis. Staff must be fully trained and experienced in
correct use of apparatus and in appropriate laboratory skills. They must have an
understanding of the principles of pesticide residue analysis and the
requirements of Analytical Quality Assurance (AQA) systems. They must
understand the purpose of each stage in the method being used, the importance
of following the methods exactly as described and of noting any unavoidable
deviations. They must also be trained in the evaluation and interpretation of the
data which they produce.
A record of training and experience must be kept for all members of staff.
2.2 When a laboratory for residue analysis is set up, the staff should spend some of
their training period in a well established laboratory where experienced advice
and training is available. If the laboratory is to be involved in the analysis for a
wide range of pesticide residues, it may be necessary for the staff to gain
experience in more than one established laboratory.
3. BASIC RESOURCES
3.1 The Laboratory
3.1.1 The laboratory and its facilities must be designed to allow tasks to be allocated to
well defined areas where maximum safety and minimum chance of
contamination of samples prevail. Laboratories should be constructed utilizing
---------------------
1
Section 3.2, Volume 2A, Codex Alimentarius (1996)
240
materials resistant to chemicals that are used in the area. Thus, under such
conditions, separate rooms would be designated for sample receipt and storage,
for sample preparation, for extraction and clean-up and for instrumentation used
in the determinative step. The area used for extraction and clean-up must meet
solvent laboratory requirements and all fume extraction facilities must be of high
quality. Receipt, storage and sample preparation can be handled in one and the
same room if only work at residue levels is being performed. The minimum
requirements for pesticide residue analytical facilities are maintenance of sample
integrity and adequate provisions for personal safety.
3.1.2 Laboratory safety must also be considered in terms of necessary and preferable
conditions as it must be recognised that the stringent working conditions
enforced in residue laboratories in some parts of the world could be totally
unrealistic in others. No smoking, eating or drinking should be permitted in the
working area. The use or application of personal, domestic or industrial
preparations for cleaning, decoration, etc., should be minimized as they may
cause contamination or other problems. Only small volumes of solvents should
be held in the working area and the bulk of the solvents stored separately, away
from the main working area. The use of highly or chronically toxic solvents and
reagents should be minimized whenever possible. All waste solvent should be
stored safely and disposed of safely and in an environmental protective manner.
3.1.3 The main working area should be designed and equipped for utilisation of a
range of analytical solvents. All equipment such as lights, macerators and
refrigerators should be "spark free" or "explosion proof". Extraction, clean-up and
concentration steps should be carried out in a well ventilated area, preferably in
fume cupboards.
3.1.4 Safety screens should be used when glassware is used under vacuum or
pressure. There should be an ample supply of safety glasses, gloves and other
protective clothing, emergency washing facilities and a spillage treatment kit.
Adequate fire fighting equipment must be available. Staff must be aware that
many pesticides have acute or chronically toxic properties and therefore, great
care is necessary in the handling of standard reference compounds.
3.2 Equipment and Supplies
3.2.1 The laboratory will require adequate, reliable, supplies of electricity and water
and various gasses, either piped or from gas cylinders, of proven quality.
Adequate supplies of reagents, solvents, glassware, chromatographic materials,
etc., are essential.
3.2.2 Chromatographic equipment, balances, spectrophotometers etc. must be

serviced and their performance validated regularly and a record of all
servicing/repairs must be maintained for every item of equipment. Calibration is
essential for equipment performing measurements.
3.2.3 Equipment performing absolute measurements, e.g., balances must be

recalibrated regularly, and records should be kept.
241
3.2.4 Although equipment may require periodic updating in order to keep up with
developments, the equipment should be sophisticated enough to do the job
required.
3.2.5 All laboratories require an adequate range of reference pesticide standards of

known and acceptably high purity. The range should cover all parent compounds
for which the laboratory is monitoring samples as well as those metabolites which
are included in MRLs.
3.2.6 All analytical standards, stock solutions and reagents must be clearly labelled
with an expiry date and stored under proper conditions. Extra care should be
taken to ensure the stability of standard reference compounds. Equal care must
be taken that standard solutions of pesticides are not decomposed by the effect
of light or heat during storage or become concentrated owing to solvent
evaporation.
4. THE ANALYSIS
4.1 Avoidance of Contamination
4.1.1 One of the major areas in which pesticide residue analysis differs significantly
from macro-analysis is that of the problem of contamination. Trace amounts of
contamination in the final samples used for the determination stage of the
method can give rise to errors such as false positive results or to a loss of
sensitivity that may prevent the residue from being detected. Contamination may
arise from construction materials, reagents, from the laboratory environment,
from the procedure, or from a combination of these. All glassware, reagents,
organic solvents and water should be checked for possible interfering
contaminants before use, by running a reagent blank through the procedure.
4.1.2 Polishers, barrier creams, soaps containing germicides, insect sprays, etc., can
give rise to interference problems and are especially significant when an
electron-capture detector is being used. There is no real solution to the problem
other than to ban their use in the laboratory.
4.1.3 Lubricants, sealants, plastics, natural and synthetic rubbers, protective gloves, oil
from ordinary compressed air lines and manufacturing impurities in thimbles, filter
papers and cotton-wool can also give rise to contamination of the final test
solution.
4.1.4 Chemical reagents, adsorbents and general laboratory solvents may contain,
adsorb or absorb compounds that interfere in the analysis. It may be necessary
to purify reagents and adsorbents and it is generally necessary to use redistilled
solvents. Deionized water is often suspected. Redistilled water is preferable.
Although in many instances, tap water or well water may be satisfactory.
4.1.5 Contamination of glassware, syringes and gas chromatographic columns can

arise from contact with previous samples or extracts. All glassware should be
cleaned with detergent solution rinsed thoroughly with distilled (or other clean)
242
water and then rinsed with the solvent to be used. Glassware to be used for
residue analysis must be kept separate.
4.1.6 Pesticide reference standards should always be stored in a room separate from
the main residue laboratory at a suitable temperature.
4.1.7 Apparatus containing plastics should be regarded as suspect and, if shown to be

a source of contamination, should not be allowed in the residue laboratory.
Other materials containing plasticisers should also be regarded as suspect but
PTFE is usually acceptable and others may be acceptable in certain
circumstances.
Analytical instrumentation should be housed in a separate room. The nature and

importance of contamination can vary according to the type of determination
technique used and the level of pesticide residue to be determined. For
instance, contamination problems which are important with methods based on
gas chromatography or high performance liquid chromatography, may well be
less significant if a spectrophotometric determination is used, and vice versa.
For relatively high levels of residues, the background interference from solvents
and other materials may be insignificant in comparison with the amount of
residue present, while many problems can be overcome by the use of specific
detectors. Furthermore, if the contaminant does not interfere with the result
being sought, its presence may be acceptable.
4.1.8 Residue and formulation analyses must be completely separated, and separate
laboratory facilities provided for each activity. Samples and sample preparation
should be kept separate from the main residue laboratory in order to preclude
cross contamination.
4.2 Reception and Storage of Samples
4.2.1 Every sample received in the laboratory should be accompanied by information

on the analysis required, on past and required storage conditions and on
potential hazards associated with the handling of that sample.
4.2.2 Upon receipt of a sample, it must immediately be allocated a unique sample

identification code which should accompany it through all stages of the analysis
to the reporting of the results. The samples should be subject to an appropriate
disposal review system and records should be kept.
4.2.3 Sample processing and sub-sampling should be carried out using procedures
which have been demonstrated to have no effect on the concentration of
residues present.
4.2.4. In an ideal situation, samples should be stored at chill (1-50C) temperature, away
from direct sunlight, and analyzed within a few days. However, in many
instances, samples may require storage for an extended period (up to 1 year)
before analysis. Storage temperature should be approximately -200C, at which
temperature degradation of pesticide residues by enzyme action is extremely
243
low. If any doubt exists, the result should be checked by analyzing fortified
samples stored under the same conditions for the same period.
4.2.5 When samples are to be frozen, it is recommended that analytical subsamples

be taken prior to freezing in order to minimize the effect of water separation as
ice crystals during storage. Extra care must still be taken to ensure that all of the
subsample is used in the analysis.
4.2.6 Neither the containers used for storage nor their caps or stoppers should allow
migration of the chemical being sought into the container. The containers must
not leak. All samples should be labelled clearly with permanent labels and
records must be kept. The extracts and final test solution should not be exposed
to direct sunlight.
4.3 Standard Operating Procedures (SOPs)
4.3.1 An SOP should be available for all routinely used operations. The SOP should
contain full experimental details as well as information on application,
performance, attainable limits of determination and method of calculation of
results. It should also contain information on any hazards arising from the
method, from standards or from reagents.
4.3.2 Any deviations from the SOP must be recorded and authorized by the analyst in
charge.
4.4 Validation of Methods
4.4.1 The amount of effort allocated to the validation of methods will vary considerably.
In a routine laboratory monitoring, for compliance with Codex MRLs or national
tolerances, standardized methods will be used in most instances. Satisfactory
performance should be demonstrated initially and thereafter checked periodically.
4.4.2 Whenever a laboratory undertakes method development and/or method

modification, the effects of analytical variables should be established, e.g., by
using a ruggedness test. Rigorous controls must be adhered to in all aspects of
methodology which may include sample size; partition volumes; variations in the
performance of the clean-up systems used; the stability of reagents or of the
derivatives prepared; the effects of light, temperature, solvent and storage on
analytes in extracts; the effects of solvent, injector, separation column, mobile
phase characteristics (composition and flow-rate), temperature, detection
system, co-extractives, etc., on the determinative system. It is most important
that the qualitative and quantitative relationships between the signal measured
and the analyte sought is established unequivocally.
4.4.3 The performance of the analytical method should be checked, both during its
development and during its subsequent use, meeting the following criteria:
- The overall average recovery of the method, determined by fortification of

blank samples, should normally be within the range of 70-120%. For a few
pesticide/substrate combinations, such recoveries may not be achievable.
244
- The reproducibility and repeatability of the method must be established by
analysis of, e.g., blank samples fortified at appropriate levels, certified
reference materials or samples with incurred residues. The relative standard
deviation should normally be less than 20%, but may be greater at lower
residue levels. Recovery of pesticides from "spiked" samples is commonly
used as a measure of efficiency of an analytical procedure, but it must be
recognized that such studies are of limited value. The evaluation of a method
should include, where possible, the extraction of labelled compounds.
4.5 Maintenance of Overall Analytical Performance
4.5.1 The performance of methods in use should be regularly assessed along the lines
indicated in section 4.4. Blank and spiked samples, both at the tolerance level
and at the lower limit of determination should also be analyzed.
4.5.2 Regular analyses of substrates known to be free of pesticide residues is

necessary in order to check that contamination is not occurring.
4.5.3 In all laboratories, regular checks should be made on the effects of changes in
batches or sources of supply of chemicals, solvents, etc.
4.5.4 Extra care should be taken so that standard solutions of pesticides are not
decomposed by the effect of light or heat during storage or become concentrated
owing to solvent evaporation. Equal care must be taken to ensure the stability of
reference standard compounds. Regular injection of standards during
chromatographic analysis of a series of samples is essential.
4.5.5 Various national and international organizations now organize collaborative

studies on particular methods and/or check sample programmes. The latter
present an ideal way for laboratories to assess their own performance. If
possible, check samples should be introduced as routine samples so that the
analyst concerned does not attempt to "make a special effort" which would
invalidate the samples as a test of laboratory performance.
4.6 Confirmatory Tests
4.6.1 When analyses are done for regulatory purposes, it is especially important that
confirmatory tests are carried out before reporting adversely on samples
containing residues of pesticides not normally associated with that commodity or
where MRLs appear to have been exceeded. As a first step, the analysis should
be repeated using the same method, if only one sample was taken through the
procedure initially. Samples may contain non-pesticidal chemicals which in some
chromatographic methods be misidentified.
4.6.2 Confirmatory tests can be divided into two types: quantitative tests are necessary
when MRLs appear to be exceeded whilst qualitative confirmation of identity is
also needed in these cases, and when atypical residues are encountered.
Qualitative tests may involve chemical reactions or separations where some loss
of the residue occurs. Particular problems occur in confirmation when MRLs are
245
set at or about the limit of determination. Although it is difficult to quantify
residues at this level, it is essential to provide adequate confirmation of identity.
4.6.3 The need for confirmatory tests may depend upon the type of sample or its
known history. In many substrates, certain residues are frequently found. For a
series of samples of similar origin which contain residues of the same pesticide, it
may be sufficient to confirm the identity of residues in a random proportion of the
samples. Similarly, when it is known that a particular pesticide has been applied
to the sample material, there may be little need for confirmation of identity,
although a random proportion of samples should be confirmed. Where control
samples are available, these should be used to check the presence of possible
interfering substances.
4.6.4 In quantitative confirmation, at least one alternative procedure should be used

and the individual results reported. In qualitative confirmation, an alternative
technique using different physicochemical properties and/or the use of spectral
data is desirable.
4.6.5 The necessary steps to positive identification are a matter of judgment on the
analyst's part and particular attention should be given to the choice of a method
which would minimize the effect of interfering compounds. The chosen method
would depend upon the availability of suitable apparatus and expertise within the
testing laboratory. As a guidance to the analyst, some alternative procedures for
confirmation are given in the following paragraphs.
4.6.6 Alternative gas chromatographic columns
The results obtained in the primary analysis should be quantitatively and

qualitatively confirmed using at least one alternative column involving a
stationary phase of different polarity. The quantitative results obtained should be
within 20% of the primary analysis. Further quantitative confirmation is required
if the results differ by more than 20%, except when the MRL is set "at or about
the limit of determination" when a difference of up to 100% of the higher value
may occur.
In choosing the alternative column material, consideration should be given to

separating any pesticidal or interfering compounds known to have retention times
on the primary column identical to that of the residue detected. The alternative
column may be a packed column or, preferably, a capillary column because of its
higher separation power. Whilst the use of an alternative gas-chromatographic
column may not always give positive confirmation, it will often quickly disprove a
suspected identity. In either case, further confirmation is required to identify the
residue.
4.6.7 Use of selective detectors for gas chromatography
When pesticides containing several chemical elements are present, detectors

showing enhanced response to these elements may be used for confirmation.
Detectors such as flame photometric (sulphur, phosphorus and tin), alkali flame
ionization (phosphorus and nitrogen), Atomic emission, Fourier-Transform Infra
246
Red and coulometric/electrolytic conductivity (nitrogen, sulphur and halogens)
can give valuable additional information on residues. The sulphur/phosphorus
response ratio obtained by using a flame photometric detector can give useful
information in the case of phosphorothioates.
4.6.8 High-performance liquid chromatography (HPLC)
HPLC can often be used advantageously for the confirmation of residues initially
found by other techniques and may be in certain circumstances the preferred
quantitative technique. Post or pre-column derivatization, the use of different
detectors and/or the acquisition of spectra, are further options available to the
analyst, especially when heat-sensitivity or low volatility make the compound to
be analyzed less amenable to gas chromatography.
4.6.9 Thin-layer chromatography (TLC)
In some instances, confirmation of gas chromatographic findings is most

conveniently achieved by TLC. Identification is based on two criteria: Rf value
and visualization reaction. The quantitative aspects of thin-layer chromatography
are, however, limited. A further extension of this technique involves the removal
of the area on the plate corresponding to the Rf of the compound of interest
followed by elution from the layer material and further chemical or physical
confirmatory analysis. A solution of the standard pesticide should always be
spotted on the plate alongside the sample extract to obviate any problems of
non-repeatability of Rf. Over-spotting of extract with standard pesticide can also
give useful information. The advantages of thin-layer chromatography are
speed, low cost and applicability to heat sensitive materials; disadvantages
include (usually) lower sensitivity than instrumental chromatographic detection
techniques and frequent need for more efficient clean-up. In some countries,
problems may be encountered when high humidity or temperature cause lack of
repeatability.
4.6.10 Column fractionation
The order of elution from liquid chromatographic columns may help to verify the
identity of a compound. Thus, an element of confirmation can be built-in to the
extraction and clean-up procedure.
4.6.11 Derivatization
This area of confirmation may be considered under three broad headings:
a. Chemical reactions
Small scale chemical reactions resulting in degradation, addition or

condensation products of pesticides, followed by re-examination of the
products by chromatographic techniques, have frequently been used. The
reactions result in products possessing different retention times and/or
detector response from those of the parent compound. A sample of standard
pesticide should be treated alongside the suspected residue so that both
247
results may be directly compared. A fortified extract should also be included
to prove that the reaction has proceeded in the presence of sample material.
Interference may occur where derivatives are detected by means of
properties of the derivatizing reagent. Chemical reactions have the
advantages of being fast and easy to carry out, but specialized reagents may
need to be purchased and/or purified.
b. Physical reactions
A useful technique is the photochemical alteration of a pesticide residue to

give one or more products with a reproducible chromatographic pattern. A
sample of standard pesticide and fortified extract should always be treated in
a similar manner. Samples containing more than one pesticide residue may
give problems in the interpretation of results. In such cases, preseparation of
specific residues may be carried out using TLC, HPLC or column
fractionation prior to reaction.
c. Other methods
Many pesticides are susceptible to degradation/transformation by enzymes.

In contrast to normal chemical reactions, these processes are very specific
and generally consist of oxidation, hydrolysis or de-alkylation. The products
possess different chromatographic characteristics from the parent pesticide
and may be used for confirmatory purposes, if compared with reaction
products using standard pesticides.
4.6.12 Mass spectrometry
Residue data obtained using mass spectrometry can represent the most
definitive evidence and, where suitable equipment is available, it is the
confirmatory technique of choice. The technique can also be used for residue
screening purposes. Mass spectrometric analysis of residues is usually carried
out in conjunction with a chromatographic separation technique to provide
retention time, ion mass/charge ratio and ion abundance data simultaneously.
The particular separation technique, the mass spectrometer, the interface
between them and the range of pesticides to be analyzed are usually
interdependent and no single combination is suitable for the analysis of all
compounds. Quantitative transmission of labile analytes through the
chromatographic system and interface is subject to problems similar to those
experienced with other detectors.
The most definitive confirmation of the presence of a residue is the acquisition of

its "complete" electron-impact ionization mass spectrum (in practice, generally
from m/z50 to beyond the molecular ion region). The relative abundance of ions
in the spectrum and the absence of interfering ions are important considerations
in confirming identity. This mode of analysis is one of the least selective and
interference from contaminants introduced during the production or storage of
extracts should be scrupulously avoided. Most mass spectrometer data systems
permit underlying interference signals (caused by, e.g., column bleed) to be
248
removed by "background subtraction" but, whilst very useful, this can sometimes
produce misleading results.
Increased sensitivity can usually be achieved by means of limited mass range

scanning or by selected ion monitoring but the smaller the number of ions
monitored (especially if these are of low mass), the less definitive are the data
produced. Additional confirmation of identity may be obtained: (1) by the use of
an alternative chromatographic column; (2) by the use of an alternative ionization
technique (e.g. chemical ionization); (3) by monitoring further reaction products of
selected ions by tandem mass spectrometry; or (4) by monitoring selected ions at
increased mass resolution.
For quantification, the ions monitored should be those which are the most
specific to the analyte, are subject to least interference and provide good
signal-to-noise ratios. Mass-spectrometric determinations should satisfy similar
analytical quality control criteria to those applied to other systems.
4.6.13 Spectral measurements
At present, little use is made of infrared, Raman or nuclear magnetic resonance

spectroscopy in pesticide residue analysis. Instrumental techniques using
multiple reflection cells, microcells, microprobes, laser light, Fourier
Transformation, etc., are being developed. These improve the quality of spectra
and enhance the sensitivity and may enlarge the application of these techniques
as detection methods for confirmation of compounds isolated by
chromatographic techniques.
4.6.14 Bioanalytical techniques
Bioanalytical techniques involving inhibition of enzyme reactions, bio-assays

using fungal spores or immunological techniques may be used as an initial
screening to determine whether a residue is present before a sample is
subjected to a more complex instrumental analysis. Immuno-assays can also be
used as a quantitative method complementary to chromatographic analysis.
4.7 The concept of Lower Practical Levels (LPL) for the Determination of
Residues of Pesticides
4.7.1 The continuing availability of improved clean up systems and more sensitive and
selective detectors has enabled residue chemists to measure lower residues.
However, the measurement of very low levels of residues may not be essential in
some circumstances.
The residue chemist is frequently involved in measuring residues in samples in

order to establish or to monitor residue levels of chemicals present in
commodities moving in international trade. In these cases, residue methods
should be sufficiently sensitive to establish and monitor against the MRL and to
determine residues likely to be present in a food sample; they need not
necessarily be so sensitive as to be able to determine residues two or more order
magnitude lower than the MRL. Methods developed to measure residues at very
249
low levels usually become very expensive and difficult to apply. However, it may
be acceptable to define a lower practical level to be determined (LPL) in any
sample. This would have the advantage of reducing the technical difficulty of
obtaining the data and would also reduce costs. The following proposals for
LPLs in various samples could be useful in enabling the residue chemist to
devise suitable methods.
4.7.2 For registered active compounds with agreed MRLs, the LPL can be specified as
a fraction of the MRL. For analytical convenience, this fraction will vary and
could be as follows:
MRL (mg/kg) LPL (mg/kg)
5 or greater 0.5
0.5 up to 5 0.1 increasing to 0.5 for higher MRLs
0.05 up to 0.5 0.02 increasing to 0.1 for higher MRLs
less than 0.05 0.5 x MRL
When the MRL is set at the limit of determination of the analytical method, the
LPL will also be at this level.
4.8 Expression of Results
For regulatory purposes, only confirmed data should be reported, expressed as

defined by the MRL. Null values should be reported as being less than an
experimentally-determined level, rather than less than a level calculated by
extrapolation. Results should not be corrected for recovery. Where positive
results derived from the analysis of several samples or duplicate measurements,
the scientifically most sound result should be evaluated and reported.
Where the results are of equal reliability, the arithmetic mean of the values
obtained should be reported. In general, for regulatory purposes, results below 1
mg/kg should be rounded to one significant figure, those from 1 to 10 mg/kg
should be rounded to two significant figures and those exceeding 10 mg/kg
should be rounded to the nearest whole number.
250
Annex VII
PRESCRIBED APPLICATION FORMS
251
REPUBLIC OF THE PHILIPPINES
DEPARTMENT OF AGRICULTURE

4TH FLOOR, BUILDING B, NIA COMPLEX, EDSA, QUEZON CITY
Tel Nos. 929-6071 LOC 123, 922-3362, 922-3364, 922-3368, 922-3371
Tel/Fax Nos. 922-3355, 922-3368
P.O. Box 2582 QUEZON CITY
“ Better harvest, health and environment through safe

and judicious use of fertilizers and pesticides”
252
253

Tel Nos. 929-6071 LOC 123, 922-3362, 922-3364, 922-3368, 922-3371
Tel/Fax Nos. 922-3355, 922-3368

254

Tel Nos. 929-6071 LOC 123, 922-3362, 922-3364, 922-3368, 922-3371
Tel/Fax Nos. 922-3355, 922-3368

255

Tel Nos. 929-6071 LOC 123, 922-3362, 922-3364, 922-3368, 922-3371
Tel/Fax Nos. 922-3355, 922-3368

256
257

Tel Nos. 929-6071 LOC 123, 922-3362, 922-3364, 922-3368, 922-3371
Tel/Fax Nos. 922-3355, 922-3368

258

Tel Nos. 929-6071 LOC 123, 922-3362, 922-3364, 922-3368, 922-3371
Tel/Fax Nos. 922-3355, 922-3368
FPA Form No. 140

NOT FOR SALE
APPLICATION FOR WAREHOUSE REGISTRATION CERTIFICATE
______ Fertilizer ______ Pesticide
259
1. Name of Dealer/Distributor and Address:
_______________________________________________________________________________________________
s
2. Name, Address and storage capacity(ies) of Warehouse(s). Please indicate the Street No., Barrio, Town/City and
Province. (Use additional sheets if necessary)
Name of Warehouse Address Storage Capacity and Total Floor Area

For Fertilizer For Pesticide
a. ________________________ _____________________________________ ________________ ________________
a. ________________________ _____________________________________ ________________ ________________
a. ________________________ _____________________________________ ________________ ________________
a. ________________________ _____________________________________ ________________ ________________
a. ________________________ _____________________________________ ________________ ________________
a. ________________________ _____________________________________ ________________ ________________
a. ________________________ _____________________________________ ________________ ________________
Date of Application: ___________________ _________________________________________________

Name and Signature of Owner or Authorized Representative

Tel Nos. 929-6071 LOC 123, 922-3362, 922-3364, 922-3368, 922-3371
Tel/Fax Nos. 922-3355, 922-3368

260
261

Tel Nos. 929-6071 LOC 123, 922-3362, 922-3364, 922-3368, 922-3371
Tel/Fax Nos. 922-3355, 922-3368

262

Tel Nos. 929-6071 LOC 123, 922-3362, 922-3364, 922-3368, 922-3371
Tel/Fax Nos. 922-3355, 922-3368

263
264

Tel Nos. 929-6071 LOC 123, 922-3362, 922-3364, 922-3368, 922-3371
Tel/Fax Nos. 922-3355, 922-3368

265
266

Tel Nos. 929-6071 LOC 123, 922-3362, 922-3364, 922-3368, 922-3371
Tel/Fax Nos. 922-3355, 922-3368
REQUIREMENTS FOR THE LICENSING OF COMMERCIAL APPLICATORS

(PEST CONTROL OPERATIONS)
FUMIGATOR/EXTERMINATOR
I. For New Applicant
1. Duly accomplished and notarized application form (FPA Form No. P-

180)
2. Copy of Certificate of Registration

a. Single Proprietorship - Copy of Certificate of Registration
Business Name with DTI
b. Corporation/Partnership - Copy of Registration with SEC
3. Copy of latest Income Tax Return (ITR) and Financial Statements (FS)
4. License Fees
5. CPA ID picture, size 1” x 1 “
6. Inspection Report and Recommendation from FPA Provincial

Coordinator
7. If the owner/manager is not a Certified Pesticide Applicator, submit

written authorization from the appointed CPA and Certificate of
Employment
II. For Renewal
For renewal; of license, all items need to be submitted except for iten no. 2 if
your DTI registration still exist. In addition, the following has to be submitted
1. Monthly Pest Control Operation Report
2. Photocopy of Certificate of Attendance in one (1) symposium

267

Tel Nos. 929-6071 LOC 123, 922-3362, 922-3364, 922-3368, 922-3371
Tel/Fax Nos. 922-3355, 922-3368

268

TH
4 FLOOR, BUILDING B, NIA COMPLEX, EDSA, QUEZON CITY
Tel Nos. 929-6071 LOC 123, 922-3362, 922-3364, 922-3368, 922-3371
Tel/Fax Nos. 922-3355, 922-3368

269
270

Tel Nos. 929-6071 LOC 123, 922-3362, 922-3364, 922-3368, 922-3371
Tel/Fax Nos. 922-3355, 922-3368

271

Tel Nos. 929-6071 LOC 123, 922-3362, 922-3364, 922-3368, 922-3371
Tel/Fax Nos. 922-3355, 922-3368

272

Tel Nos. 929-6071 LOC 123, 922-3362, 922-3364, 922-3368, 922-3371
Tel/Fax Nos. 922-3355, 922-3368

273

Tel Nos. 929-6071 LOC 123, 922-3362, 922-3364, 922-3368, 922-3371
Tel/Fax Nos. 922-3355, 922-3368

274

Tel Nos. 929-6071 LOC 123, 922-3362, 922-3364, 922-3368, 922-3371
Tel/Fax Nos. 922-3355, 922-3368

275
Annex VIII
RISK APPRAISAL CHECKLIST FOR

“GOOD HOUSEKEEPING COMPLIANCE
CERTIFICATE”
276
277
278
Annex IX
LIST OF BANNED AND RESTRICTED

PESTICIDES
279
BANNED AND RESTRICTED PESTICIDES IN THE PHILIPPINES1
RATIONALE
Pesticides have been of great benefit to agriculture. They have minimized crop
damage by insects, weeds, plant diseases, rodents and other pests. They have saved
lives through control of disease-carrying insects. Generally, they have provided a higher
quality of life for man.
Pesticides, however, are poisons that, if used improperly or without sufficient

knowledge of their side effects, can endanger man and animals. Moreover, potential
hazards to human health and wildlife can be created by residues from some persistent
pesticides that may build-up in the food chain and cause contamination of the
environment.
Given the benefits of pesticides, the critical challenge now is to institute strong
and extensive mechanisms to prevent pesticides from harming human health and the
environment. The primary purpose of Presidential Decree 1144, creating the Fertilizer
and Pesticide Authority (FPA), is to address this challenge. It does so through a process
of pesticide registration.
Registration of pesticides, active ingredients and formulations, is one of the most

basic operations of pesticide regulatory agencies. This mechanism ensures that any
pesticide made available to the end-users is considered safe for use through the
examination of the data in support of its registration submitted by the manufacturers
through their distributors. Biological efficacy, chemical, physical and toxicological data
are evaluated.
As a result of this evaluation process, compounds have been classified into

banned and restricted pesticides.
BANNED PESTICIDES are not to be brought into and used in this country, under
any circumstances.
-------------------------------
1
As amended by Pesticide Circular No. 4, Series of 1989, and FPA Board Resolution Nos. 01 (1993) and 01
(1999).
280
GUIDELINES ON RESTRICTED PESTICIDES
A restricted pesticide is covered by two basic guidelines:
A. They may not be allowed for distribution, sale and use in certain crops and/or
areas of the country, and;
B. They may be used only by and under the supervision of certified applicators, or
under such conditions as the FPA Administrator may require.
CLASSIFICATION OF RESTRICTED PESTICIDES
The list of restricted pesticides is categorized as follows:
1. Those which are not for importation except in cases of emergency. Such
cases are to be determined by the Authority.
2. Those to be used for termite control only.
3. Those to be used under specific limitations.
4. Fumigants and other chemicals for use only by certified fumigators.
STOP SALE
STOP USE
REMOVAL AND
HOLD ORDER
When a pesticide is being offered for sale or used in violation of this Restriction
Notice, the FPA through its authorized representative, may issue and enforce stop sale,
stop use, removal or hold order to the owner or custodian of said pesticide, offering it to
be held at a designated place until the law or the Rules and Regulations of this Authority
shall have been complied with; or until all said violations have been disposed by the
proper authorities.
The provisions of Presidential Decree 1144 and the FPA Rules and Regulations
and their penal provisions shall apply for violations of this circular.
281
BANNED AND RESTRICTED PESTICIDES
IN THE PHILIPPINES
I. Banned Pesticides
1. Parathion-ethyl
2. Copper aceto-arsenite (Paris Green)
3. DDT containing mosquito coil
4. DBCP
5. Nitrofen
6. Leptophos
7. EPN
8. Endrin
9. Mercuric fungicides
10. Toxaphene
11. Elemental phosphorus (white and yellow)
12. Thalium sulfate
13. 1-Naphthylthiourea (ANTU)
14. Gophacide
15. Sodium fluoroacetate
16. Sodium fluoroacetamide (1081)
17. Strychnine
18. 2, 4, 5-T
19. Aldrin
20. Dieldrin
21. Heptachlor
22. Chlorodimeform
23. EDB
24. HCH/BHC
25. Methyl parathion
26. Organotin compounds
27. Azinphos Ethyl
28. Chlordane
II. Restricted Pesticides
A. Importation Not Allowed Except in Cases of Emergency as

Determined by the Authority
1. Aldicarb
2. Chlorobenzilate
B. For Use Under Specific Limitations
1. DDT - All uses cancelled except for malaria control purposes by

the Department of Health.
282
2. Endosulfan - Not for use near aquatic system and in paddy rice.
The concentration will be reduced to 5% EC or
lower for other uses (FPA Board Resolution No. 01,
1993).
3. Monocrotophos – Allowed use is for beanfly control on legumes

only (FPA Board Resolution No. 01, 1993).
4. Too Hazardous for General Use

(For Institutional Use Only)
a. Paraquat - Restricted for Institutional Use Only. Approval

of use will be based on strict compliance by the
importer/end-user of the requirements set for its
use.
b. Phenamiphos - For use in banana and pineapple

plantations only.
c. Ethoprop - For use in banana plantations only.
d. Methidathion - For use in banana plantations only.
e. Inorganic Arsenicals (Arsenic Trioxide) - For use by FPA

accredited wood treatment and wood preserving
plants only.
f. Lindane (Gamma/BHC) - The only allowed use to date is

on pineapple plantations by soil pre-plant
application.
g. Pentachlorophenol - For use in wood treatment only by

FPA accredited wood treatment plants and
institutions.
C. Fumigants and Other Chemicals for Use Only by Certified

Fumigators
Adequate time for aeration is required after treatment before

commodities are processed into food or feed.
1. Methyl bromide
2. Carbon disulfide
3. Phosphine generating compounds
4. HCN-generating materials
5. Carbon tetrachloride
6. Chloroform
7. Ethylformate
283
Annex X
ADDITIONAL CIRCULARS ON RESTRICTIONS

OF SPECIFIC PESTICIDE PRODUCTS
284
285
December 15, 1989
Pesticide Circular No. 04

Series of 1989
To: : All Concerned
Subject : REVISED LIST OF BANNED AND RESTRICTED PESTICIDES

IN THE PHILIPPINES
Pursuant to its declared regulatory policy of conducting a periodic evaluation of

the existing list of Banned and Restricted Pesticides in the Philippines (Pesticide circular
No. 9 Series of 1981 is amended and superceded by Pesticide Circular No. 5 Series of
1983) this Authority hereby releases this newly revised list.
This new list specifically addresses the so-called Dirty Dozen issue. The policy
recommendations were discussed with the agricultural pesticide industry in consonance
with existing protocols on regulatory actions by this Authority.
With the concurrence of the Chairman of the Board, Secretary Carlos G.

Dominguez, this list is being issued and shall be effective immediately. It supercedes all
previous lists, specifically Pesticide Circular No.9 Series of 1981 and Pesticide Circular
No. 5 Series of 1983.
For your immediate compliance.
(SGD)
LUIS T. VILLA-REAL, JR.
Executive Director III
286
FPA REGULATORY POLICY ON THE DIRTY DOZEN PESTICIDES2
PESTICIDE PREVIOUS REGULATORY NEW REGULATORY POLICY

STATUS
1. PARATHION (Ethyl) BANNED CONTINUE BAN STATUS
2. 2,4,5-T - RESTRICTED FOR BANNED

EMERGENCY CASES
ONLY AS MAY BE
DETERMINED BY THE
AUTHORITY
- NO EXISTING
REGISTRATION WITH
FPA
3. PARAQUAT RESTRICTED FOR RESTRICTED FOR

INSTITUTIONAL USE ONLY INSTITUTIONAL USE ONLY.
APPROVAL OF USE WILL
BE BASED ON STRICT
COMPLIANCE BY THE
IMPORTER/ END-USER OF
THE REQUIREMENTS SET
FOR ITS USE.
4. DDT RESTRICTED FOR USE RESTRICTED

ONLY BY THE
DEPARTMENT OF HEALTH ALL USES CANCELLED
FOR MALARIA CONTROL EXCEPT FOR MALARIA
CONTROL PURPOSES OF
THE DEPARTMENT OF
HEALTH
5. ENDRIN BANNED CONTINUE BANNED

STATUS
DIELDRIN RESTRICTED BANNED
ALDRIN RESTRICTED FOR TERMITE BANNED

CONTROL ONLY
6. CHLORDIMEFORM - NO EXISTING BANNED

REGISTRATION WITH
FPA
- NO CURRENT
RESTRICTION
7. DBCP BANNED - CONTINUE BANNED
STATUS
2
Attachment to Pesticide Circular No.4, Series of 1989
287
PESTICIDE PREVIOUS REGULATORY NEW REGULATORY POLICY
STATUS
8. CHLORDANE RESTRICTED FOR BANNED
TERMITE CONTROL ONLY
BY FPA CERTIFIED
APPLICATORS
HEPTACHLOR - RESTRICTED FOR BANNED

TERMITE CONTROL
ONLY BY FPA
CERTIFIED
APPLICATORS
- RESTRICTED USE IN
PINEAPPLE
PLANTATIONS FOR
CONTROL OF WHITE
GRUBS
9. HCH RESTRICTED FOR DIRECT BANNED

IMPORTATION IN SUGAR
PLANTATION
LINDANE/ GAMMA BHC NO CURRENT RESTRICTED

RESTRICTION
THE ONLY ALLOWED USE
TO DATE IS ON PINEAPPLE
PLANTATIONS BY SOIL
PRE-PLANT APPLICATION
10. ETHYLENE DIBROMIDE RESTRICTED BANNED

(EDB)
11. CAMPECHLOR/ - NO CURRENT BANNED

TOXAPHENE RESTRICTION
- NO EXISTING
APPLICATION FOR
REGISTRATION WITH
FPA
12. PCP NO CURRENT SEVERELY RESTRICTED

(PENTACHLOROPHENOL) REGULATORY ACTION FOR WOOD TREATMENT
ONLY BY FPA ACCREDITED
WOOD TREATING PLANTS
AND INSTITUTIONS.
288

Tel Nos. 929-6071 LOC 123, 922-3362, 922-3364, 922-3368, 922-3371
Tel/Fax Nos. 922-3355, 922-3368
We the members of the Board of Directors of the Fertilizer and

Pesticide Authority, through our authorized representatives, at the
meeting held on 20 April 1999 at the OSEC Conference Room,
Department of Agriculture, do hereby ratify the following Resolutions as
indicated by the signatures appearing below.
RESOLUTION NO. 01-99
Approving the Recommendation of the Pesticide Policy and

Technical Advisory Committee (PPTAC) banning the use of Chlordane
and its formulated products in the Philippines. Such a recommendation
was duly endorsed by the Fertilizer and Pesticide Authority (FPA).
Companies engaged in the formulation, distribution and marketing of
Chlordane or any product containing Chlordane are given fifteen (15)
days after publication of this notice to dispose of their stocks.
Chlordane or any product containing Chlordane found in the

possession of distributors or dealer fifteen (15) days after the
publication of this notice shall be confiscated by the government for
proper disposal at the expense of the importer/dealers as part of their
product stewardship responsibility. Pest Control Operators who may
have stocks of Chlordane in their possession are given three (3)
months from publication to phase-out their stocks. Thereafter, the
remaining stocks shall be confiscated for proper disposal at the
expense of the holder.

289

Tel Nos. 929-6071 LOC 123, 922-3362, 922-3364, 922-3368, 922-3371
Tel/Fax Nos. 922-3355, 922-3368

290
Annex XI
CROP GROUPINGS
291
CROP GROUPINGS1
PORTION OF COMMODITY TO
CLASSIFICATION OF COMMODITIES WHICH THE CODEX MRL
APPLIES (AND WHICH IS
ANALYZED)
GROUP 1 - ROOT AND TUBER VEGETABLES
Root and tuber vegetables are starchy foods derived from the enlarged solid roots,
tubers, corms or rhizomes, mostly subterranean, of various species of plants. The
underground location usually protects the edible portion from pesticides applied
during the growing season. The entire vegetable may be consumed.
Root and tuber vegetables: Whole commodity after removing

tops. Wash the roots or tubers in
Arrowroot Potato, sweet
cold running water, brushing
Beets, Sugar Radish gently with a soft brush to
remove loose soil debris, if
Carrot Taro
necessary, and then dab lightly
Cassava, Bitter or Sweet Tugui with clean tissue paper to dry.
For carrots, after drying the tops
Ginger Turmeric
are carefully cut off with a knife
Parsley Turnip by cutting through the bottom of
the stem at the lowest point of
Parsnips Water chestnut
attachment of the outer petioles.
Potato Yam, True (ubi) If an annulus of root tissue is
thereby severed from hollow-
Yam Bean
crown roots, the material should
(Singkamas)
be re-combined with the roots.
Representative Commodities
Carrot Potato
Radish
1
Adopted from FAO Manual on Submission and Evaluation of Pesticide Residues Data for the
Estimation of MRL (Appendix VI).
292
ANALYZED)
Group 2 - BULB VEGETABLES
Bulb vegetables are pungent flavorful foods derived from the fleshly scale bulbs, or
growth buds of alliums of the lily family (Liliaceae). Subterranean growth protects the
bulb from the direct application of pesticide during the growing season. The entire
bulb may be consumed following the removal of the parchment-like skin.
Bulb Vegetables: Remove adhering soil (e.g. by

rinsing in running water or by
Garlic
gentle brushing of the dry
Leek commodity).
Bulb/dry onions and garlic:
Onion, Green and bulb
Whole commodity after removal
Representative Commodities of roots and whatever parchment
skin is easily detached.
Onion, Green and bulb Leeks and spring onions:
Whole commodity after removal
of roots and adhering soil.
Group 3 - LEAFY VEGETABLES (EXCEPT BRASSICA VEGETABLES)
Leafy vegetables (except Group 4 vegetables) are foods derived from the leaves of a wide variety of
edible plants including leafy parts of Group 1 vegetables. These leaves are fully exposed to pesticides
applied during the growing period. The entire leaf may be consumed. Leafy vegetables of the brassica
family are grouped separately.
Leafy Vegetables: Whole commodity after removal

of obviously decomposed or
Alugbati Beets, sugar, leaves withered leaves.
Celery Carrot, leaves
Kangkong Cassava, Bitter or
Lettuce, Head and sweet
leafy Parsnips, leaves
Melon, Bitter, leaves Potato, Sweet, leaves
Pepper leaves Radish, leaves
Saluyot Taro, leaves
Spinach Turnip, leaves
Squash Malunggay
Lettuce Potato, sweet, leaves
Spinach
293
ANALYZED)
Group 4 - BRASSICA (COLE) LEAFY VEGETABLES
Brassica (cole) leafy vegetables are foods derived from the leafy parts, stems and
immature inflorescences of plants commonly known and botanically classified as
brassicas and also known as cole vegetables. The edible parts are fully exposed to
pesticides applied during the growing season. The entire vegetable may be
consumed.
Brassica leafy vegetables: Whole commodity after removal

Brocolli Cauliflower
withered leaves. For cauliflower
Brussel sprouts Mustard and headed broccoli, analyze
flower head and stems,
Cabbage Mustard, Chinese
discarding leaves. For
Cabbage, Chinese (Pechay) sprouts, analyze “buttons” only.
Cabbage, Savoy
Cabbage Pechay
Group 5 - STEM VEGETABLES
Stem vegetables are foods derived from the edible stems or shoots of a variety of
plants.
Stem vegetables: Whole commodity after removal

Artichoke Celery
withered leaves.
Asparagus Chicory (wit loof) Rhubarb and asparagus: stems
Bamboo shoots Gabi Stalk only.
Banana Heart Rhubarb Celery and asparagus: remove
adhering soil (e.g. by rinsing in
running water or by gentle
brushing of the dry commodity).
294
ANALYZED)
Group 6 - LEGUME VEGETABLES
Legumes are derived from the dried or succulent seeds and immature pods or leguminous plants
commonly known as beans and peas. Pods are fully exposed to pesticides during the growing season.
Dried forms are fully exposed to post harvest treatments. Succulent forms may be consumed as whole
pods or as shelled product. Legume fodder is in Group 18.
Legume Vegetables: Whole commodity.

Beans, Asparagus Cowpea
(winged bean) Peas, Chick (garbanzo)
…Common …Garden (chicharo)
(habichuela) …Sweet
…Kidney Soybeans
…Lablab
…Lima
…Mung
…Snap
…String (sitao)
Beans, Mung Peas, Garden (chicharo)
…String (sitao) Soybeans
Group 7 - FRUITING VEGETABLES - EDIBLE PEEL
Fruiting vegetables - edible peel (except cucurbits) are derived from the immature or
mature fruits of various plants, usually annual vines or bushes. These vegetables are
fully exposed to pesticides during the growing season. The entire fruiting vegetables
may be consumed.
Fruiting Vegetables - edible peel: Whole commodity after removal

of stems.
Bitter gourd Pepper, Sweet and Chili
Eggplant Tomato
Okra Malunggay
Eggplant Tomato
295
ANALYZED)
Group 8 - FRUITING VEGETABLES - INEDIBLE PEEL
Cucurbit vegetables are derived from the immature or mature fruits of various plants,
usually annual veins or bushes. Fruits are fully exposed to pesticides during the
growing season. Edible portion is protected by skin, peel or husk which is removed or
discarded before consumption.
Fruiting vegetables - inedible peel: Whole commodity after removal

of stems.
Cantaloupe Kundol
Chayote Melon, Musk
Cucumber Pumpkin
Gherkins Squash
Gourd, edible Watermelon
Cantaloupe Squash
Cucumber
Group 9 - CITRUS FRUITS
Citrus fruits are produced by trees of the Rutaceae family and are characterized by
the aromatic oily peel, globular form and interior segments of juice-filled vesicles. The
fruit is fully exposed to pesticides during the growing season. The fruit pulp
may be consumed in succulent form or as a beverage. The entire fruit may be used
for preserving.
Citrus fruit: Whole commodity.

Calamondin Orange (cahel)
(calamansi) Pomelo
Lemon Grapefruit
Mandarin
Naranghita
Calamondin Pomelo
296
ANALYZED)
Group 10 - POME FRUITS
Pome fruits are produced by trees related to the genus Pyrus of the family
(Rosaceae). They are characterized by the fleshy tissue surrounding a core
consisting of parchment-like carpels enclosing the seed. The entire fruit, except the
core, may be consumed in the succulent form or after processing.
Pome fruits: Whole commodity after removal

of stems.
Apple Pear
Chico
Group 11 - STONE FRUITS
Stone fruits are produced by trees related to the genus Prunus of the rose family
(Rosaceae) characterized by the fleshy tissue surrounding a single hard-shelled
seed. The fruit is fully exposed to pesticides applied during the growing season. The
entire fruit except seed, may be consumed.
Stone fruits: Whole commodity after removal

of stems and stones but the
Apricot Prunes
residue calculated and
Cherry Nectarines expressed on the whole
commodity without stem.
Sour cherry Peach
Sweet cherry Plums
Group 12 - SMALL FRUITS AND BERRIES
Small fruits and berries are derived from a variety of plants whose fruit is
characterized by a high surface-weight ratio. The fruits are fully exposed to pesticides
applied during the growing season. The entire fruit, often including the seed, may be
consumed in a succulent or processed form.
Small fruits and berries: Whole commodity after removal

of caps and stems. Currants; fruit
Bignay Grapes
with stems.
Blackberries Mulberry
Blueberries Raspberries
Currants Strawberries
Dewberries
297
ANALYZED)
Group 13 - ASSORTED FRUITS - EDIBLE PEEL
Assorted fruits- edible peels are derived from the immature or mature fruits of a
variety of plants, usually shrubs or trees from tropical or subtropical regions. The
whole fruit may be consumed in a succulent or processed form.
Assorted fruits - edible peel: Dates and olives: whole

commodity after removal of
Dates Olives
stems and stones but residue
Figs Guava calculated and expressed on the
whole fruit.
Figs: Whole commodity.
Group 14 - ASSORTED FRUITS - INEDIBLE PEEL
Assorted fruits - inedible peels are derived from the immature or mature fruits of
different kinds of plants, usually shrubs or trees from tropical or subtropical regions.
Edible portion is protected by skin, peel or husk. Fruit may be consumed in fresh or
processed form.
Assorted fruits- inedible peel: Whole commodity unless

qualified.
Avocado Mango
Pineapples: after removal of
Banana Papaya crown.
Guava Passion fruit Avocados and mangoes: whole
Jackfruit Pineapple commodity after removal of stone
but calculated on the whole fruit.
Kiwi fruit Bananas: after removal of crown
tissue and stalks.
298
ANALYZED)
Group 15 - CEREAL GRAINS
Cereal grains are derived from the clusters of starchy seeds produced by a variety of
plants primarily of the grass family (Graminae). The edible seeds are protected at
varying degrees from applied pesticides during the growing season by the husk.
Post-harvest treatments are common. Husks are removed before consumption.
Cereal grains: Whole commodity.

Corn Triticale Fresh corn and sweet corn:
kernels plus cob without husk.
Rice Rye
Barley Sorghum
Maize Sweet corn
Oats Wheat
Pearl millet
Corn Rice
Group 16 - STALK AND STEM CROPS
Stalk and stem crops are various kinds of plants, mostly of the grass family
(Graminae) cultivated extensively for animal feed and for production of sugar. Stems
and stalks used for animal feeds are consumed as succulent forage, silage, or as dry
fodder or hay. Sugar crops are processed.
Stalk and stem crops: Whole commodity.

Corn forage, fodder and straw
Rice forage, fodder and straw
Barley fodder and straw
Grass fodders
Sorghum fodder
Sugarcane
Corn forage Rice forage
299
ANALYZED)
Group 17 - LEGUME OILSEEDS
Legume oilseeds are mature seeds from legumes cultivated for processing into edible vegetable oil or
for direct use as human food.
Legume oilseeds: Whole commodity after removal

of shell.
Peanuts Soybean
Group 18 - LEGUME ANIMAL FEEDS
Legume animal feeds are various species of legumes used for animal forage, grazing, fodder, hay or
silage with or without seed. Legume animal feeds are consumed as succulent forage or as dried fodder
or hay.
Legume and Animal Feeds: Whole commodity.

Alfalfa fodder Mungbean pods
Bean fodder Pea fodder
Clover fodder Peanut fodder
Mungbean leaves Soybean leaves
Mungbean pods Soybeans
Group 19 - TREE NUTS
Tree nuts are seeds of a variety of trees and shrubs which are characterized by a hard, inedible shell
enclosing an oil seed. The seed is protected from pesticides that were applied during the growing
season by other parts of the fruit and the shell. The edible portion of the nut is consumed in succulent,
dried, or processed form.
Tree nuts: Whole commodity after removal

of the shell.
Almonds Pecans
Chestnuts: whole in skin.
Cashew nuts Pili nuts
Chestnuts Walnuts
Macademia nuts
Cashew nuts Pili nuts
300
ANALYZED)
GROUP 20 - OILSEED
Oilseed consists of the seed from a variety of plants used in the production of edible
vegetable oils. Some important vegetable oilseeds are by-products of fiber or fruit
crops.
Oilseed: Whole commodity.

Cottonseed Safflowerseed
Linseed Sunflowerseed
Rapeseed
GROUP 21 - TROPICAL SEEDS
Tropical seeds consist of the seeds from several tropical and semitropical trees and
shrubs mostly used in the production of beverages and confections. Tropical seeds
are consumed after processing.
Tropical seeds: Whole commodity.

Cacao beans Coffee beans
Group 22 - HERBS
Herbs consist of leaves, stems and roots from a variety of herbaceous plants used in
relatively small amount to flavor other foods. They are consumed in succulent or
dried form as components of other foods.
Herbs: Whole commodity.

Oregano Pandan
Group 23 - SPICES
Spices consist of aromatic seeds, roots, fruits and berries from a variety of plants
used in relatively small amounts to flavor other foods. They are consumed primarily
in the dried form as components of other foods.
Spices: Whole commodity.

Achuete Black pepper
301
ANALYZED)
Group 24 - TEAS
Teas are derived from the leaves of several plants, but principally Camellia sinensis.
They are used in the preparation of infusions for consumption as stimulating
beverages. They are consumed as extracts of the dried or processed product.
Teas: Whole commodity.

Tea, black
Group 25 - MEATS
Meats are the muscular tissue, including the adhering fatty tissue from animal
carcasses prepared for wholesale distribution. The entire product may be consumed.
Meats: Whole commodity. (For fat-

soluble pesticides a portion of
Carcass meat (and carcass fat)
carcass fat is analyzed and
Carcass meat of cattle MRLs apply to carcass fat.)3
Carcass meat of goat
Carcass meat of horse
Carcass meat of pig
Carcass meat of dog
Carcass meat of sheep
Carcass meat of rabbit
Group 26 - ANIMAL FATS
Animal fats are the rendered or extracted fatty tissue of animals. The entire product
may be consumed.
Animal fats: Whole commodity.

Cattle fat Sheep fat
Pig fat
3
For milk and milk products regarding the soluble pesticides see Section 1 of FAO Manula on the
Submission and Evaluation of Pesticide Residues Data for the Establishment of MRL
302
ANALYZED)
Group 27 - MEAT BY-PRODUCTS
Meat by-products are edible tissues and organs, other than meat and animal fat, from
slaughtered animals as prepared for wholesale distribution. Examples: liver, kidney,
tongue, heart. The entire product may be consumed.
Meat byproducts (such as liver, kidney, etc.): Whole commodity.

Cattle meat by-products
Goat meat by-products
Pig meat by-products
Sheep meat by-products
Group 28 - MILKS
Milks are the mammary secretions of various species of lactating herbivorous

ruminant animals, usually domesticated. The entire product may be consumed.
Milks Whole commodity. For fat-

soluble compounds, a portion of
the fat is analyzed but the
residue is expressed on a whole
commodity basis on the
assumption that milk contains
4% fat.
Group 29 - MILK FATS
Milk fats are the fats rendered or extracted from milk.
Milk fats Whole commodity.
Group 30 - POULTRY MEATS
Poultry meats are the muscular tissues, including adhering fats and skin, from poultry
carcasses as prepared for wholesale distribution. The entire product may be
consumed.
Poultry meats: Whole commodity. (For fat

soluble pesticides a portion of
Poultry meats (carcass fats)
carcass fat is analyzed and
MRLs apply to carcass fat).
303
ANALYZED)
Group 31 - POULTRY FATS
Poultry fats are the rendered or extracted fats from fatty tissues of poultry. The entire
product may be consumed.
Poultry fats Whole commodity.
Group 32 - POULTRY BY-PROUCTS
Poultry by-products are edible tissue and organs, other than poultry meat and poultry
fat, from slaughtered poultry.
Poultry by-products Whole commodity.
Group 33 - EGGS
Eggs are the fresh edible portions of the reproductive body of several avian species.
The edible portion includes egg white and egg yolk after the removal of the shell.
Eggs Whole egg whites and yolks

combined after removal of shells.
Group 34 - GRASS FORAGE, FODDER AND HAY
Any grass, Gramineae family, (either green or cured) except sugarcane and those
included in the group cereal grains and legumes that will be fed to or grazed by
livestock, all pasture and range grasses and grasses grown for hay or silage.
Grass forge, fodder and hay: Whole commodity.

African stargrass Guinea grass
Bagokbok Napier grass
Cogon Para grass
Group 35 - NON-GRASS ANIMAL FEEDS (FORAGE, FODDER, STRAW AND

HAY)
Non-grass animal feeds: Whole commodity.

Ipil-ipil Stylo
Kudzu
304
ANALYZED)
Group 36 - FISH
Fish are gilled, aquatic vertebrates and cartilaginous animals in various species,
usually wild as prepared for wholesale distribution. Exposure to pesticides is through
animal metabolism. The entire product may be consumed.
Fish Whole commodity.
Group 37- SHELLFISH
Shellfish are aquatic animals of various species, wild or cultivated, having an inedible
inner or outer shell. Exposure to pesticides is through animal metabolism. The entire
product exclusive of the shell may be consumed.
Shellfish Whole commodity after removal

of shell.
Group 38 - PRODUCTS NOT CLASSIFIED FOR GROUP TOLERANCES
Carambola Mangosteen
Chesa Pomegranate
Coconut Rambutan
Durian Rimas
Kamias Santol
Kaong Soursop (guyabano)
Lanzones Star apple
Litchi Sugar apple (atis)
Mabolo Tamarind
Makopa
305
Annex XII
REPORTING OF HANDLERS
306

Tel Nos. 929-6071 LOC 123, 922-3362, 922-3364, 922-3368, 922-3371
Tel/Fax Nos. 922-3355, 922-3368
FPA Form No. 200
MONTHLY PEST CONTROL OPERATION REPORT
For the month of ___________
307
List of Chemicals Used Purpose Quantity Name and Address Remarks
Source(s) of Chemicals (Hazards Observed)
(Brand Names) (Target Pest) Used of Client
Certified true and correct: Submitted by:
_______________________________ __________________________________
FPA Certified Pesticide Applicator Name & Address of Company
Control No. _____________

Tel Nos. 929-6071 LOC 123, 922-3362, 922-3364, 922-3368, 922-3371
Tel/Fax Nos. 922-3355, 922-3368

308
309

Tel Nos. 929-6071 LOC 123, 922-3362, 922-3364, 922-3368, 922-3371
Tel/Fax Nos. 922-3355, 922-3368

310
Annex XIII
FPA MANUAL ON OCCUPATIONAL SAFETY
311
FPA MANUAL ON OCCUPATIONAL AND TECHNICAL SAFETY OF PESTICIDE
MANUFACTURING, FORMULATION, REPACKING PLANTS, WOOD TREATMENT
PLANTS AND OTHER INSTITUTIONAL USERS
I. Introduction
The Fertilizer and Pesticide Authority (FPA) was created on May 30, 1977
under Presidential Decree 1144. As mandated by law, FPA is charged with the
power to regulate the importation, exportation, manufacture, formulation,
distribution, sale, transport, storage, use and disposal of pesticides.
Pesticides are important chemical inputs in the country where they are
extensively used both in agriculture and in public health programs. Their adverse
effects on human health and environment are generally acknowledged.
On the basis of a mathematical model, WHO estimates that about

500,000 cases of pesticide poisoning, resulting in 5,000 deaths occur each year.
Jeyaratnam, in his studies in Sri Lanka, extrapolated that about 2.9 million cases
of acute pesticide poisoning requiring admission to hospitals with about 220,000
deaths are likely to occur annually in developing countries.
The FPA and the Department of Health (DOH) monitor, through public
hospitals, the cases and causes of pesticide poisoning on a nationwide basis.
During the eight (8) year period from 1980 to 1987, a total of four
thousand thirty one (4,031) cases were reported: 2,594 or 64.35% were suicidal;
714 or 17.71% were accidental; 558 or 13.84% were occupational; and 165
cases or 4.1% were not specified.
Of the total number of reported cases, 3,185 or 79% recovered; and 603
or 15% died. Sixty one (61) or 1.5% of the cases were transferred and 82 or
2.0% of the cases were not specified as to its disposition.
The male population had a higher number of incidents at 2,193 or 54.40%

compared to female, which numbered at 1,838 or 45.60%.
A detailed summary of pesticide poisoning cases from 1980-1987 is

appended to this Manual.
The FPA instituted the National Pesticide Safety Program in 1979 through
the Agro-medical services unit with the primary objective of training medical and
paramedical personnel on the recognition, treatment and management of
pesticide poisoning cases. Through the Department of Health, monitoring of
pesticide poisoning cases is done at the rural health units, emergency, provincial
and regional hospital levels. Over the last three (3) years, about 2,263 doctors
and paramedical personnel have attended these seminars. First-aid kits
containing supplies for the initial management of pesticide poisoning cases were
distributed to rural health units and hospitals. To date, 412 of these have been
312
given to hospitals in identified pilot areas. Training modules have also been
conducted for Agro-pesticide dealers, pesticide applicators and farm technicians.
II. Hazards
The FPA has classified pesticides based on toxicity and hazard (see
Table 1).
Table 1. Classification of Pesticides Based on Toxicity and Hazard 1
Acute Oral, LD50 Acute Dermal, LD50

Category and Signal Color Band (Rat) (mg/Kg BW)
Words Symbol 2 3
Solid Liquid Solid Liquid
CATEGORY I 50 200 100 400

RED or or or or
DANGER: POISON less less less less
CATEGORY II 51 201 101 401

YELLOW to to to to
WARNING: HARMFUL 500 2000 1000 4000
CATEGORY III 501 2001 Over Over

BLUE to to 1000 4000
CAUTION 2000 3000
CATEGORY IV Over Over

GREEN N/A N/A
----------- 2000 3000
1
Toxicity classification based on formulation.
The FPA Classification Table is adopted from the World Health Organization (WHO)
Classification By Hazards, the only modification being in the Title and combination of
Categories 1a and 1b of the WHO Table into Category I for FPA.
2
The following shades must be used as norms: Pantone red 199-C, Pantone yellow-C, Pantone
blue 293-C and Pantone green 347-C.
3
The terms “solid” and “liquid” refer to the physical state of the product or formulation being
classified.
313
Table 2 shows the WHO recommended classification of pesticides by
hazard. The present WHO statement reclassifies pesticides not only according
to their acute toxicities but also takes into consideration chronic toxicities and
local irritation.
The hazard referred to is generally the acute risk to health (that is, the risk
of single or multiple exposures over a relatively short period of time) that might
be encountered accidentally by any person handling the product in accordance
with the directions for handling by the manufacturer or in accordance with the
rules laid down for storage and transportation by competent international bodies.
Table 2. WHO Recommended Classification of Pesticides by Hazard
LD50 for the rat (mg/kg body weight)

Class Oral Dermal
Solids Liquids Solids Liquids
Ia Extremely hazardous 5 or < 20 or < 10 or < 40 or <
Ib Highly hazardous 5 – 50 20 – 200 10 – 100 40 - 400
II Moderately hazardous 50 – 500 200 – 2000 100 – 1000 400 - 4000
III Slightly hazardous Over 500 Over 2000 Over 1000 Over 4000
The classification distinguishes between the more and the less hazardous
forms of each pesticide in that it is based on the toxicity of the technical
compound and on its formulations. In particular, allowance is made for the lesser
hazards from solids as compared with liquids.
The classification is based primarily on the acute oral and dermal toxicity
to the rat since these determinations are standard procedures in toxicology.
Where the dermal LD50 value of a compound is such that it would place it in a
more restrictive class than the oral LD50 value would indicate, the compound will
always be classified in the more restrictive class. Provision is made for the
classification of a particular compound to be adjusted if, for any reason, the acute
hazard to man differs from that indicated by LD50 assessments alone.
Absorption of Pesticides
Pesticides may be absorbed into the body by three specific routes – by

ingestion, inhalation or through the skin.
1) Ingestion : usually accidental or suicidal
2) Inhalation : inhalation of mist or powder may cause absorption

through the mucous membrane of the nose, mouth or
respiratory passages.
3) Skin Absorption : most likely route by which occupational poisoning may

occur.
314
III. Organizational Aspects
A specific management person should be designated as responsible for

safety. A functioning safety committee is needed with 50% management input
and 50% worker and occupational health input. That means representatives will
come from management, workers, engineering and medical profession. The task
is to lay down policies, supervise the implementation of rules and monitor any
accident and/or health problems.
Periodic interval audit of occupational health, industrial hygiene, safety

and security, environmental and public protection should be undertaken on a
monthly basis.
Specific safety training should be provided to each worker for his/her job
before employment. Periodic general safety training should be provided for all
workers with at least eight (8) hours per year or two (2) hours per quarter.
Specific workplace hazards to human health must be communicated as part of
this training to give workers reasons for following work rules.
IV. Occupational Health
A. Staffing and Training
Occupational health staffing and training of occupational health

staff must be in accord with section 1963.02 of DOLE regulations for first-
aiders, nurses, and physicians.
Safety/First Aid training should be conducted:
a. Occupational health personnel: Physicians and nurses working in

establishments where pesticides are used must have been
accredited by the Department of Labor and Employment (DOLE).
The company should submit certification to the FPA. Other
paramedical staff should be trained and accredited by the
Philippine National Red Cross (PNRC) or by the Safety
Organization of the Philippines (SOPI).
b. Workers: all workers (regular, contractual, permanent, casuals)

handling pesticides must undergo pre-placement and periodic
training on the proper and safe handling of pesticides, proper use
of personal protective clothing and equipment, basic knowledge of
the chemicals they are handling and first aid procedures in cases
of poisoning. Periodic general safety training should be
conducted for a minimum of eight (8) hours per year or two (2)
hours per quarter. Specific workplace hazards must be
communicated to the workers to ensure compliance.
315
B. Health Examinations
Pre-placement, periodic and exit health examinations are required

for all permanent, contractual and casual personnel working with
pesticides.
Health examinations will consist of the following minimum

requirements which will be provided by the employer free of charge:
1. Complete and thorough physical examination which will be

properly recorded and kept in the clinic.
2. Laboratory tests which shall include:
a. Hematology – hemoglobin, hematocrit, leucocyte count,

and differential, reticulocyte and platelet count.
b. Chest X-ray
c. Urinalysis
d. Fecalysis
e. Biochemical monitoring – BUN, creatinine, uric acid, total

protein, alkaline phosphatase, total cholesterol, SGOT and
SGPT.
3. Special examinations, whenever applicable and necessary are the

following:
a. For organophosphate and carbamate compounds -

nerve conduction test.
b. For organochlorine compounds such as lindane and

heptachlor - EKG, FBS, OGTT, Triglycerides, LDL and
HDL quarterly.
c. For arsenic and pentachlorophenol - monthly pulmonary

function tests.
d. For paraquat – monthly pulmonary function tests.
4. Biologic monitoring will be as follows:
a. For organophosphate and carbamates - red cell

cholinesterase activity determinations; if red cell testing is
not available, do serum or white blood cholinesterase
determinations.
316
b. For organochlorine, in particular, lindane -
mutagenicity test is recommended.
c. For inorganic arsenicals and pentachlorophenols -

urinary level determinations of the chemicals are required.
d. For paraquat - urinary paraquat level determinations are

done.
Workers exposed to Category I-II pesticides should have semi-

annual examination (twice a year) consisting of a complete medical
examination, hematologic, liver, and kidney function tests. Workers
exposed to Category III-IV should have annual medical and laboratory
examinations.
To ensure the safety of workers, only regular personnel shall be

allowed to work in formulating/manufacturing plants and institutions
handling Category I-II pesticides. Casuals should not be allowed to
handle AI or technical materials.
C. Biological Monitoring
1. General Guidelines:
a. Testing to be done as recommended.
b. All workers manifesting signs and symptoms of toxicity

should have biological monitoring.
c. Only results from laboratories recognized and accredited

by the FPA and/or Bureau of Research and Laboratory-
DOH will be acceptable.
d. Return to work orders can only be issued by the company

doctors.
2. Cholinesterase testing for permanent, contractual and casual

personnel exposed to cholinesterase-inhibiting compounds should
be done.
Baseline Cholinesterase is determined as follows:
a. No exposure to organophosphorus and carbamate

compounds for at least 30 and 14 days, respectively prior
to extraction.
b. No alcohol intake for at least 2 days.
c. Mean of two (2) determinations with 24-hour interval but

not to exceed three (3) days between the 2 testings with
317
blood extraction done at the same time of day or at most
+/- 30 minutes of the first extraction. If the result of the two
(2) determinations varies within 15%, the mean of the two
(2) determinations shall be the baseline level. If the results
show variability greater than 15%, a third determination
should be done, ensuring that factors that can affect the
RBC cholinesterase levels are eliminated (such as acute
alcoholic intoxication, exposure to organophosphates and
carbamates).
Regular cholinesterase determination, the frequency of which

would vary depending on the toxicity category of the pesticide and
the type of work done (see Table 3).
Table 3. Frequency of Cholinesterase Determinations *
Hours of exposure/day
Type of work
3-4 hrs/day >4 hrs/day
When exposed to Category I-II pesticides (AI):
Mixer/loader/blender Every 2 weeks Weekly
Sprayman/packager Every 3 weeks Every 2 weeks
Flagman/capper/filler Every 3 weeks Every 2 weeks
When exposed to Category III-IV pesticides:

Mixer/loader Every 4 weeks Every 3 weeks
Sprayman/packager Every 8 weeks Every 6 weeks
Flagman/capper/filler Every 8 weeks Every 6 weeks
*this is applicable to work schedule of 5 days/week
Levels of cholinesterase (ChE) activity should be interpreted by

the occupational health physician with the following guidelines:
a. Asymptomatic, with 20-25% depression from pre-exposure

value of RBC and whole blood ChE, respectively must be
investigated and repeat RBC or whole blood ChE done.
b. Asymptomatic, with 30-50% or greater depression from

pre-exposure value of RBC and whole blood ChE,
respectively, the worker must be removed from further
exposure to anti-ChE pesticides.
c. Symptomatic, with 20-25% or greater depression from pre-

exposure value of RBC and whole blood ChE, respectively
must be evaluated by the physician and treated
appropriately and removed from further exposure to anti-
ChE pesticides.
318
d. Workers must not be exposed again to ChE-inhibiting
compounds until further tests show they are fully recovered
from signs/symptoms of cholinergic excess (if
symptomatic) and/or cholinesterase activity of the red cell
or whole blood ChE is within 20% of the pre-exposure
value.
e. Return to work certification can only be issued by the

company physician.
Cholinesterase levels and action taken for low levels must be

properly recorded for every worker. The suggested format is
shown in Figure 1.
Figure 1. Personal ChE Record
Name:
Date Product Nature of ChE Action taken
Handled Work
3. Urinary Arsenic and Pentachlorophenol (PCP)
Baseline levels are determined from samples collected

after 7 days of no exposure.
Periodic follow-up sampling of workers’ urine is to be

collected after at least 4 days of work, or equivalent to 36 hours of
exposure, on a monthly basis.
Any worker with signs and symptoms should have a

urinary testing.
For methods, see Appendix II.
4. Urinary Paraquat
Baseline monitoring to be determined from sample

collected after 7 days of no exposure.
Periodic monitoring to be determined from sample

collected at least 4 hours and not greater than 8 hours after
ceasing Paraquat exposure, on a monthly basis.
319
Any worker with signs and symptoms should have a
urinary testing.
5. Blood chromosomal tests for Organochlorine (specifically

Lindane and Heptachlor)
Baseline monitoring:
Periodic monitoring to be undertaken at least on a semi-

annual basis.
D. First Aid
An emergency clinic should be provided for all hazardous

workplaces regardless of the number of workers.
The minimum personnel requirement for plants/plantations/pest

control establishments handling Category I-II pesticides is shown in
Table 3.
Table 4 shows the emergency medicines and medical supplies

and equipment for pesticide formulating plants, plantations, and pest
control establishments handling Category I-II pesticides.
320
Table 3. Professional Services Schedule for Workers Exposed
to Category I-II Pesticides*
Number of Workers Personnel

1 - 10 1 First Aider
Part-time Nurse
Occupational Health Consultant
11 - 50 2 First Aiders
Full-time Nurse
Part-time Physician 2 hrs 3x/week
Full-time Nurse
Full-time Dentist 2 hrs 3x/week
Full-time Nurse
Full-time Physician 4 hrs 5x/week
Full-time Nurse
Full-time Physician 4 hrs 5x/week
601 and above 1 First Aider for every 30 workers
1 Nurse for every 300 workers
1 Dentist for every 600 workers
1 Physician for every 600 workers
* Based on amendment to Labor Code of the Philippines 1986.
321
Table 4. List of Emergency Medicines and Medical Supplies
and Equipment for Pesticide Formulating Plants,
Plantations, and Pest Control Establishments Handling
Category I-II Pesticides.
A. Medicines
1. Systemic-Acting
a. Atropine Sulfate - ampule (1 mg/mL)
tablet (0.6 mg/mL)
b. Diazepam - ampule (5 mg/mL)
tablet (5 mg/mL)
c. Phenytoin - ampule (100 mg/mL)
capsule (100 mg/mL)
d. Glucose 5% in distilled water (500 mL for vunoclysis)
e. Ddopamine - ampule (40 mg/mL)
f. Tetanus Toxoid ampule
g. Phytonadione - ampule (10 mg/mL)
(Vitamin K1)
h. Sodium bicarbonate 7.5% - 50 ml ampule
i. Any antihistaminic ampule and tablet
j. Any coronary vasodilator ampule or sublingual tablet or
capsule
k. Anti-hypersensitive ampule and tablet
2. Locally-acting
a. Topically antiseptic (Providone-Iodine)
b. 70% ethyl alcohol
c. Hydrogen peroxide 3%
d. Silver-sulfadiazine ointment/cream for burns
e. Local anesthetic ointment and 1-2% ampule/vial for local
infiltration anesthesia
f. Activated charcoal (Merck – 90% adsorbent, fine)
g. Eye-wash solution
B. SUPPLIES AND EQUIPMENT
1. Sterile gauze pads 12. Venoclysis with butterfly

2. Gauze bandage, roll needles (gauge 20, 21,
3. Triangular bandage 23) and “Soluset”
4. Adhesive tape, roll 13. Stethoscope
5. Absorbent cotton (sterile) 14. Sphygmomanometer
6. Bandage scissors 15. Mouth tube (for adult)
7. Tongue depressors 16. Otoscope
8. Splinter forceps 17. Flash light
9. Hot water bag 18. Examining table
10. Ice bag 19. Portable stretcher with
11. Disposable needle and flatboard (at least 5 feet)
syringes 20. Rubber tourniquet
21. Suctioning bulb
322
Continuation of Supplies and Materials
22. Nasogastric tube (Adult) 31. Oxygen mask (half-mask)

23. Medicine cabinets 32. Nasal catheter for oxygen
24. Thermometer 33. Surgical instruments for
25. Ophthalmoscope suturing (forceps, iris,
26. Linens scissors, 4-0 cotton
27. Waste sanitary pail (with suture, surgical knife)
cover, foot-operated) 34. Splint
28. Hospital bed for 35. Tourniquets
observation 36. Suction apparatus
29. Ambu bag
30. Oxygen tank with
regulator and humidifier
V. Industrial Hygiene
A. Personal Protective Clothing and Equipment (PPE)
1. Recommendations for OPs and carbamates:
Protective clothing and equipment must be provided by the

employer free of charge. The following table shows the
recommended personal protective clothing and equipment (PPE).
Table 5. Recommended Protective Clothing and

Equipment
I. For Category I-II Pesticides:
A. Handling of technical materials and formulated

products with open equipment (loading, mixing,
spraying):
1. Chemical resistant gloves with reverse gauntlets
2. Protective head covering of chemical-resistant
material
3. Face shield
4. Chemical-resistant apron
5. Full body cover-alls (siliconized cotton) without
cuffs
6. Respirator, half mask with replaceable activated
charcoal cartridge whenever liquid formulation is
volatile, solvent is xylene or formulation is
malodorous
7. Chemical-resistant footwear (boots)
323
(cont’n of Table 5)
B. Handling of sealed, non-leaking containers:

1. Full body cover-alls (siliconized cotton or
chemical-resistant materials)
2. Chemical-resistant gloves
C. Handling and Laundering of contaminated clothes:

1. Chemical-resistant gloves
2. Chemical-resistant footwear
3. Chemical-resistant apron
II. For Category III-IV Pesticides:
A. Liquid Formulation
1. Handling of technical material with open

equipment (mixing, repacking and spraying)
a. Chemical resistant gloves (seamless)
b. Full body cover-alls (cotton)
c. Rubber boots
d. Half masks with activated charcoal
replaceable cartridge
2. Handling of close containers

a. Chemical-resistant gloves (seamless)
b. Chemical-resistant apron
c. Cotton cover-alls
B. Granular, powder or dust formulation
1. Handling of technical material (mixing and

spraying)
e. Full body cover-alls (cotton)
f. Chemical-resistant gloves (seamless)
g. Rubber boots
h. Half face masks or dust mask
i. Face shield
2. Handling of close containers

a. Chemical resistant gloves (seamless)
b. Chemical-resistant apron
c. Cover-alls
324
2. Recommendations for Arsenicals and PCP:
a. lightweight cover-all
b. knee high boots (chemical-resistant)
c. gauntlet gloves (chemical-resistant)
d. face masks, shields or goggles
e. below knee length apron (chemical-resistant)
f. carbon filter respirators
g. in case of spillage, workers involved in clean-up must wear
same PPE.
3. Recommendations for Paraquat:

a. coveralls, (double-weave)
b. knee high boots (chemical –resistant)
c. gauntlet gloves (chemical-resistant)
d. cloth mask with activated charcoal filter
e. below knee length apron (chemical-resistant)
f. in case of spillage, workers involved in clean-up must wear
respirators and goggles.
4. Recommendations for Lindane:

a. coveralls (double weave)
b. boots knee high (chemical-resistant)
c. face shield and carbon filter respirator.
5. General Guidelines for Maintenance:
a. Decontamination and Laundering of Protective Clothing
Provision must be made for the frequent and

regular decontamination and washing of dirty clothing,
either by the company’s own facilities or by those of an
approved contract service. The decontamination agent
may be 5% sodium carbonate solution. The clothing must
be soaked for at least one (1) hour prior to laundering.
Machine laundering is necessary for arsenic, PCP,
paraquat, heptachlor, lindane and category I-II OPs and
carbamates. Care must be made that these clothings are
not taken home for laundering or for other purposes.
b. Maintenance of Protective Clothing and Equipment
Protective clothing and equipment must be

regularly checked and maintained to ensure that its
condition is satisfactory. Gloves and boots must be
checked for leaks before use and after cleaning. Gloves
must be decontaminated prior to cleaning.
325
B. Personal Hygiene
Changing and washing facilities must be provided with personal

lockers for personal and work clothes. A clean area must be provided
separate from the “dirty” area where workers enter after work.
A separate clean area should be provided where workers can eat,

drink, and smoke. Eating, drinking and smoking must not be allowed in
the work area.
VI. Safety and Security
Machinery should be maintained and shielded as necessary to reduce

hazards. A closed system (automatic or semi-automatic) is required for Category
I-II materials.
Emergency equipment to meet accidents must be provided such as

emergency showers and eyewash facilities. In plantations or in the field,
provision of water at work area of 25 gallons/person or minimum of 100 gallons
per area, whichever is greater.
A safety committee should be established (see Organizational Aspects).
Maintain healthful work environment by requiring health personnel to

conduct regular appraisal of workplace including all the facilities therein in order
to detect occupational health hazards. The physician must be informed of the
exact time, place and the type of pesticide to be used including the number of
workers exposed.
Fire-fighting equipment must be provided and strategically located. Signs

indicating smoking restrictions, access restrictions, the location of emergency
equipment, re-entry time, and all escape routes must be prominently displayed.
Each team of workers must have at least one (1) person trained on first-
aid treatment of poisoning.
All emergency and safety-related equipment must be frequently and

regularly checked and maintained. Records should be kept of all inspection
checks and maintenance carried out on the equipment.
Secure arrangements must be made to prevent undesired access to site.
Storage of chemicals and treated wood (i.e. in wood treatment plants)

should be adequate so as to prevent contamination.
326
REFERENCES
1. Jeyaratnam, O. Health problems of pesticide usage in the third world.

British Journal of Industrial Medicine, 1985; 42:505-506.
2. Occupational Safety and Health Standards, Department of Labor, 1984.
3. WHO Document, VBC 178.692, Spectrophotometric kit for measuring

cholinesterase activity.
4. WHO Document, VBC 84.889, Field methods for measuring blood

cholinesterase activity.
5. WHO Document, VBC 84.2, The WHO recommended classification of

pesticides by hazard.
6. Manual for Seminar on Occupational Safety and Health, The Safety

Organization of the Philippines, Inc.
7. Biological Monitoring in Organophosphate Exposure, Department of

Health, New Zealand, 1982.
327
APPENDIX I
SAFE HANDLING OF PESTICIDES
1. Read the Label:
The label provides useful information regarding pesticide use, dangerous

properties, precautions and emergency procedures in cases of poisoning.
2. Use the Recommended Personal Protective Clothing and Equipment

(PPE) (See Table 1):
After pesticide application, the worker must shower and change his
clothing. The work clothes must be decontaminated and laundered
separately from general laundry everyday. Street clothes should not be
worn under protective clothing.
3. Store Safely:
Store pesticides only in original containers; never in food, beverages,

feed and seed storage.
Store pesticides in cabinets, room or storage area that can be locked,

secured from children, irresponsible persons and animals.
Store pesticides away from food, feed and seed storage.
4. Mix Safely:
When mixing, utmost care should be taken. A stick should be used to

dilute or mix the solution or mixture. Because of the danger of skin
absorption, mixing must never be done with bare hands.
5. Avoid Spray Drift:
This is essential to prevent contamination of the worker through skin

absorption or by inhalation.
6. Clean-up Spillages:
This can effectively be done with soil, sawdust, sand, etc. to absorb the
material. The contaminated soil can be shoveled into open drums for
safe disposal. The area should be washed down into copious amount of
water. Washings should be effectively contained and disposed of safely.
328
7. Wash Carefully:
Wash hands and face before smoking or eating. After working with
pesticide, take a shower and change to clean clothing.
8. Dispose Used Containers in a Safe Manner:
Bottles should be broken and drums punctured before disposal. Bury

container at least 50 centimeters deep in an isolated area away from
water supplies.
9. Be Prepared for Emergencies:
In spite of all precautions, instances of pesticide poisoning sometime

occur, so know the symptoms or signs of poisoning. Follow label
directions for immediate aid. Call physician.
10. General Rules:
a) In all cases, call a physician at once.

b) In cases of skin contact, wash thoroughly with soap and running
water for at least 15 minutes and remove contaminated clothing.
c) If pesticide was splashed into the eyes, flush with gentle stream of
running water for at least 15 minutes.
d) If pesticide was swallowed, follow label directions.
329
APPENDIX II
METHODS OF CHOLINESTERASE DETERMINATION
A. Michel Method
This method is based upon measurement of the acid produced by the

action of cholinesterase upon acetylcholine. The acid production is measured in
terms of the pH produced by enzymatic activity in a standard buffer solution over
a definite period of time. The pH is measured with a glass electrode.
B. Ellman (Spectrophotometric) Method
The enzyme activity is measured by determining the rate of thiochline

formation due to enzyme gydrolysis of acetylthiocholine used as substrate.
Thiocholine reacts with a reagent dithiobisnitrobenzoic acid forming a yellow
complex, the intensity of which is measured spectrophotometrically. The more
yellow complex formed in a unit of time, the higher the enzyme activity. Since
the original method requires laboratory facilities, WHO has promoted the
development of a kit which enables measurement of blood cholinesterase activity
spectrophotometrically in the field. Unpublished Document WHO/VBC/84.888
available from Pesticide Development and Safe Use Unit, Vector Biology Control
Division, WHO, Geneva.
C. Tintometric Method
The principle of the method is the measurement of the change of pH in a

reaction mixture. The blood cholinesterase hydrolyzes acetylcholine, liberating
acetic acid. The rate of this reaction (and thus the enzyme activity of the known
amount of blood) is measured by the range of color change of an indicator
(bromothymol blue) present in the solution. A mixture of blood, indicator and
acetylcholine perchlorate is prepared and allowed to stand for a fixed time
depending on the temperature. The change in colors produced by change in pH
is matched against the colors on a comparator disc.
330
APPENDIX III
WHO LIST OF CATEGORY I PESTICIDES
List of Technical Products Classified in Category I
Name Chemical Type LD50 (mg/Kg)

aldicarb C 0.93
arsenous oxide 180
calcium cyanide 39
chlorfenviphos OP 10
chlormephos OP 7
chlorthiophos OP 7.1
coumaphos OP 16
crimidine 1.25
CVP
cyanthoate OP 3.2
cycloheximide 2
DBCP
demephion-0 and –S OP 15
demeton-0 and -S OP 1.7
dibromochloropropane 170
dieldrin OC 10
dimefox OP 1
disulfoton OP 2.6
EPN OP 14
ethoprophos OP 26
ethoprop
ethylthiometon
fenamiphos OP 15
fensulfothion OP 3.5
fonofos OP 8
fosthietan OP 5.7
hexachlorobenzene 10 000
leptophos OP 50
M74
MBCP
mephosfolan OP 9
mercuric chloride 1
metaphos
mevinphos OP 4
parathion OP 13
parathion-methyl OP 14
phenylmercury acetate 30
phorate OP 2
phosfolan OP 9
phosphamidon OP 17
331
Continuation of List of Technical Products Classified in Category I
prothoate OP 8
red quill
schradan OP 9
scilloriside c0.5
sodium fluoroacetate 0.2
sulfotep OP 5
fluoroacetamide 13
formetanate C 21
heptenophos OP 96
IPSP OP 84
isazofos OP 60
isofenphos OP 28
isothionate OP 150
isoxathion OP 112
lead arsenate 10
mercarbam C 36
medinoterb acetage NCP 42
methamidophos OP 30
methidathion OP 25
methacarbate C 19
methomyl C 17
2-methoxymethyl-mercury chloride OM 30
methyl-merkapto-phosteolovy
methylmercury dicyandiamide OM 32
metilmarkapto-phosoksid
metriltriazotion
monocrotophos OP 14
MPP
nicotine 50
nitrilacarb C 9
omethoate OP 50
oxamyl C 6
oxydemeton-methyl OP 65
paris green 22
pentachlorophenol NCP 80
phenylmercury nitrate OM
pirimiphos-ethyl OP 140
propaphos OP 70
propetamphos OP 75
salithion OP 180
sodium arsenite 10
sodium cyanide 6
strychnine 16
TBT
thiofanox C 8
332
thiometon OP 120
thioxamyl
triamiphos 20
triazophos OP 82
triazotion
vamidothion OP 103
zinc phosphide 45
TEPP OP 1.1
terbufos OP c2
thionazin OP 11
thiofos
timet
trichloronat OP 15
acrolein 46
aldoxycarb C 27
aldrin OC 98
allyl alcohol 64
aminocarb C 50
antu 8
azinphos-ethyl OP 12
azinphos-methyl OP 16
azocyclotin OT 80
bis (tributyltin) oxide 194
blasticidin-S 16
bromophos-ethyl OP 71
butocarboxim C 158
butoxycarboxim C 288
calcium arsenate 20
carbofuran C 8
carbophenothion OP 32
carbophenothio methyl OP 157
chlordecone OC 114
crotoxyphos OP 74
DDVF
DDVP
delnav
demeton-S-methyl OP 40
demeton-S-methylsulfan OP 37
diamidafos OP 190
diclorvos OP 56
dicrotophos OP 22
dimetilan C 47
dinoseb NCP 58
dinoseb acetate NCP 60
dinoterb NCP 25
333
dioxathion OP 23
DMTP
DNBP
DNBPA
DNOC NCP 25
EDDP
medifenphos OP 150
endothion OP 30
endrin OC 7
ESP OP 105
fenthion OP 330
flucythrinate PY 67
334
APPENDIX IV
DUTIES OF THE OCCUPATIONAL HEALTH PHYSICIAN
1. To assess the incidence and prevalence of ill-health in relation to work

conditions and to recognize work conditions that contribute to subclinical and
overt ill health and its short-term and long-term consequences. He needs
special knowledge and experience in: toxicology, physiology, biostatistics,
psychology, technological hazards, and internal medicine.
2. To identify occupational health problems in the light of the general health of

the working population.
3. To manage adequately accidents and other emergencies (e.g. cardiovascular

incidents, cases of intoxication); involves diagnosis, first-aid treatment and
organization of a first-aid service and a disaster programme.
4. To prepare and evaluate statistical records of sickness, absences, to use

such records to identify causes, and to propose measures to eliminate
causes.
335

FPA GreenBook PDF

Uploaded by

Copyright:

Available Formats

FPA GreenBook PDF

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

FPA GreenBook PDF

Uploaded by

Copyright:

Available Formats

TABLE OF CONTENTS

Chapter 1 MANDATE AND STRUCTURE OF THE FERTILIZER AND 1

1.1 MANDATE AND FUNCTIONS OF THE FERTILIZER AND

1.2 ORGANIZATIONAL STRUCTURE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Chapter 2 REGISTRATION OF CHEMICAL PESTICIDES 5

2.1 GENERAL INFORMATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

2.2 APPLICATION FOR REGISTRATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

2.3 DATA REQUIREMENTS FOR REGISTRATION AND

2.4 EXPERIMENTAL USE PERMITS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

2.6 GROUNDS FOR DENIAL OF REGISTRATION . . . . . . . . . . . . . . . . . . . . . . . 32

2.7 OBLIGATIONS OF REGISTRANTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

2.8 LABELLING REQUIREMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

2.9 SAMPLE STATEMENTS: WARNING AND PRECAUTIONS,

2.10 REFERENCES TO ACCEPTABLE PROTOCOL . . . . . . . . . . . . . . . . . . . . . . 49

Chapter 3 POLICY GUIDELINES ON BIORATIONAL PESTICIDES 64

3.1 DEFINITION AND SCOPE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65

3.3 PRODUCT SPECIFICATION DATA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69

3.5 RESIDUE ANALYSIS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77

3.6 NON-TARGET ORGANISM HAZARD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80

3.7 ENVIRONMENTAL FATE AND EXPRESSION . . . . . . . . . . . . . . . . . . . . . . . 89

3.8 PRODUCT PERFORMANCE DATA REQUIREMENTS . . . . . . . . . . . . . . . . 92

3.9 EXPERIMENTAL USE PERMIT GUIDELINES . . . . . . . . . . . . . . . . . . . . . . . 93

3.10 PROMOTING BIORATIONAL PESTICIDES . . . . . . . . . . . . . . . . . . . . . . . . . 96

Chapter 4 LICENSING, CERTIFICATION AND ACCREDITATION OF 109

4.1 LEGAL BASIS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110

4.2 APPLICATION AND REQUIREMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110

4.4 “GOOD HOUSEKEEPING” REQUIREMENT FOR LICENSING OF

4.5 CERTIFICATION AND ACCREDITATION . . . . . . . . . . . . . . . . . . . . . . . . . . . 113

Chapter 5 PRODUCT STEWARDSHIP AND RESPONSIBLE CARE 126

5.1 GENERAL INFORMATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127

5.2 RESTRICTIONS ON AVAILABILITY AND USE . . . . . . . . . . . . . . . . . . . . . . . 128

5.3 FORMULATION AND PACKING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133

5.4. PACKAGING MATERIALS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139

5.5 TRANSPORT, STORAGE, AND DISPOSAL . . . . . . . . . . . . . . . . . . . . . . . . . 148

Chapter 6 POST REGISTRATION ACTIVITIES 164

6.1 GENERAL INFORMATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 165

6.2 MONITORING ACTIVITIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 165

6.3 COMPLIANCE IN MONITORING OF PRODUCT STEWARDSHIP . . . . . . . . 166

6.4 PESTICIDE RESIDUES (MRL ESTABLISHMENT) . . . . . . . . . . . . . . . . . . . . 167

6.5 INSPECTION OF HANDLERS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 173

6.6 IMPORTATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 173

6.7 STORAGE AND DISPOSAL OF BANNED PESTICIDES . . . . . . . . . . . . . . . 174

6.8 DATA COLLECTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 174

6.9 TRAINING AND EDUCATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 175

Chapter 7 PENALTIES FOR VIOLATIONS 176

7.1 PRE-REGISTRATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 177

7.2 GROUNDS FOR REVOCATION OF LICENSE . . . . . . . . . . . . . . . . . . . . . . . 177

7.3 POST-REGISTRATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 178

7.4 ENFORCEMENT OF ACTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 178

8.1 STOCKS OF ANTIDOTES AND FIRST AID SUPPLIES

8.2 INSPECTION OF BOOKS AND RECORDS . . . . . . . . . . . . . . . . . . . . . . . . . 180

8.3 PROHIBITED ADVERTISING PRACTICES . . . . . . . . . . . . . . . . . . . . . . . . . . 182

8.4 PESTICIDE PRICING POLICY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 183

8.5 TECHNICAL REVIEW/EVALUATION OF REGISTERED

GLOSSARY OF TERMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 187

Figure 1 Schematic Diagram of the Pesticide Product Registration

Figure 2 Relationships Among Conventional Pesticides, Biological

Figure 3 Environmental Fate Testing Scheme . . . . . . . . . . . . . . . . . . . . . . . . . . . 90

Table 1 Schedule of Revised Fees and Charges For Pesticide Product