Various Outdoor Sites - End Use Products: Data Requirements for Use Site Category (USC # 32)

Various Outdoor Sites - End Use Products

Data Requirements for Use Site Category ( USC # 32): Various Outdoor Sites - EP
Data Code Title Data required Conditions Volume No and Pages
0 Index R    
1 Label R    
3 Chemistry Requirements for the Registration of Manufacturing Concentrates and End-Use Products Formulated from Registered technical grade of active ingredients or integrated system products      
3.1 Product Identification      
3.1.1 Applicant's Name and Office Address R    
3.1.2 Formulating Plant's Name and Address R    
3.1.3 Trade Name R    
3.1.4 Other Names R    
3.2 Formulation Process      
3.2.1 Description of Starting Materials R    
3.2.2 Description of the Formulation Process R    
3.2.3 Discussion of the Formation of Impurities of Toxicological Concern CR If applicable  
3.3 Specifications      
3.3.1 Establishing Certified Limits R    
3.3.2 Control Product Specification Form R    
3.4 Product Analysis      
3.4.1 Enforcement Analytical Method R    
3.4.2 Impurities of Toxicological Concern CR If applicable  
3.5 Chemical and Physical Properties      
3.5.1 Colour CR Required for manufacturing concentrates only  
3.5.2 Physical State R    
3.5.3 Odour CR Required for manufacturing concentrates only  
3.5.4 Formulation Type R    
3.5.5 Container Material and Description R    
3.5.6 Density or Specific Gravity R See 8.2.1  
3.5.7 pH R    
3.5.8 Oxidizing or Reducing Action (Chemical Incompatibility) R    
3.5.9 Viscosity R    
3.5.10 Storage Stability Data R    
3.5.11 Flammability R    
3.5.12 Explodability R    
3.5.13 Miscibility R    
3.5.14 Corrosion Characteristics R    
3.5.15 Dielectric Breakdown Voltage R    
3.6 Sample(s) CR If requested by PMRA  
3.7 Other Studies/Data/Reports CR If available  
4 Toxicology      
4.1 Summaries R    
4.6 Acute Studies - EP      
4.6.1 Acute Oral R    
4.6.2 Acute Dermal R    
4.6.3 Acute Inhalation R    
4.6.4 Primary Eye Irritation R    
4.6.5 Primary Dermal Irritation R    
4.6.6 Dermal Sensitization R    
4.6.7 Potentiation/Interaction CR If available  
4.6.8 Other Acute Studies CR If available  
4.7 Short-term Studies - EP CR Depending on use pattern, required if any component of the EP may increase absorption of the active ingredient(s) or increase toxic or pharmacologic effects  
4.7.1 Short-term Oral (90-day rodent) CR See 4.7  
4.7.2 Short-term Oral (90-day and/or 12-month dog) CR See 4.7  
4.7.3 Short-term Dermal (90-day) CR See 4.7  
4.7.4 Short-term Dermal (21/28-day) CR See 4.7  
4.7.5 Short-term Inhalation (21/28-day) CR See 4.7  
4.7.6 Short-term Inhalation (90-day) CR See 4.7  
4.7.7 Other Special Studies CR See 4.7  
4.8 Other Studies/Data/Reports CR If available  
5 Exposure (Occupational and/or Bystander)      
5.1 Summaries R    
5.2 Use Description/Scenario (Application and Post Application) R    
5.4 Mixer/Loader/Applicator- Passive Dosimetry Data CR One of 5.4 or 5.5 is required if there is potential for exposure  
5.5 Mixer/Loader/Applicator-Biological Monitoring Data CR See 5.4  
5.8 Dermal Absorption CR May be required if the margin of safety is inadequate  
5.11 Glove/Clothing Penetration Data CR May be required for risk mitigation purposess or for inadequate margin of safety  
5.13 Package Integrity Study CR Required if packaged in water soluble bags  
5.14 Other Studies/Data/Reports CR    
8 Environmental Chemistry and Fate      
8.1 Summaries R    
8.2 Laboratory Studies      
8.2.1 Summary of Physicochemical Properties to Include, Solubility in Water, Vapour Pressure, Octanol:Water Partition Coefficient, Dissociation Constant, UV-Visible Absorption, Density or Specific Gravity (See parts 2 and 3) R See 2.14.7, 2.14.9, 2.14.11, 2.14.10, 2.14.13, 2.14.6, and 3.5.6  
8.2.3 Laboratory Studies of Transformation      
8.2.3.1 Summary R    
8.2.3.6 Special Studies Related to Use-Pattern or Formulation CR    
8.2.4 Laboratory Studies of Mobility      
8.2.4.1 Summary CR    
8.2.4.6 Special Studies Related to Use-Pattern or Formulation CR    
8.3 Field Studies of Dissipation/ Accumulation [May be Small- or Large-Scale]      
8.3.1 Summary R    
8.3.4 Special Studies Related to Intended Use Pattern CR Based on concerns arising from results of other studies  
8.4 Storage, Disposal and Decontamination (TGAI or EP)      
8.4.1 Summary R    
8.5 Other Environmental Fate Studies (TGAI or EP)      
8.5.1 Summary CR Based on concerns arising from results of other studies  
8.6 Other Studies/Data/Reports CR If available  
9 Environmental Toxicology      
9.1 Summary CR    
9.2 Non-Target Terrestrial Invertebrates      
9.2.1 Summary R    
9.2.8 Laboratory Studies CR If there is a potential for exposure and components of the EP are of concern  
9.2.9 Field Studies CR Based on concerns arising from results of other studies  
9.3 Non-Target Freshwater Invertebrates      
9.3.1 Summary CR    
9.3.5 Laboratory Studies CR If components of the EP are of concern  
9.3.6 Field Studies CR Based on concerns arising from results of other studies  
9.5 Fish      
9.5.1 Summaries CR    
9.5.4 Laboratory Studies CR If components of the EP are of concern  
9.5.5 Field Studies CR Based on concerns arising from results of other studies  
9.6 Wild Birds      
9.6.1 Summary CR    
9.6.4 Laboratory Studies CR If there is a potential for exposure and components of the EP or the EP itself (e.g., granular formualtions, pellets or baits) are of concern.  
9.6.5 Field Studies CR Based on concerns arising from results of other studies  
9.6.6 Special Studies Related to the Intended Use-Pattern (TGAI and EP) CR See 9.6.5  
9.7 Wild Mammals      
9.7.1 Summary CR Based on concerns arising from results of other studies  
9.7.2 Field Studies CR See 9.7.1  
9.8 Non-Target Plants      
9.8.1 Summary CR    
9.8.6 Laboratory Studies CR If components of the EP are of concern  
9.8.7 Field Studies CR Based on concerns arising from results of other studies  
9.9 Other Studies/Data/Reports CR If available  
10 Value (applicable to each pest/site or host combination)      
10.1 Value Summaries R    
10.2 Efficacy Studies      
10.2.1 Mode of Action R    
10.2.2 Description of Pest Problem R    
10.2.3 Efficacy Trials      
10.2.3.1 Summaries R    
10.2.3.2 Efficacy: Laboratory, Growth Chamber Trials CR    
10.2.3.3 Efficacy: Small-scale Trials (Field, Greenhouse) R One or both of 10.2.3.3 or 10.2.3.4 may be required  
10.2.3.4 Efficacy: Operational Trials CR See 10.2.3.3  
10.3 Adverse Effects on Use Site      
10.3.1 Summaries R    
10.3.2 Non-Safety Adverse Effects [e.g.: to crop, site of application (discoloration, corrosion), etc.] R    
10.4 Economics CR    
10.5 Sustainability      
10.5.1 Survey of Alternatives (chemical and non-chemical) CR    
10.5.2 Compatibility with Current Management Practices Including IPM CR    
10.5.3 Resistance Management CR    
10.5.4 Contribution to Risk Reduction CR    
10.6 Other Studies/Data/Reports CR If available  
12.5 Foreign Reviews      
12.5.3 Foreign Reviews of Chemistry Requirements for MAs and EPs formulated from registered TGAIs or ISPs      
12.5.4 Foreign Reviews of Toxicology      
12.5.5 Foreign Reviews of Exposure (Occupational and/or Bystander)      
12.5.8 Foreign Reviews of Environmental Chemistry and Fate      
12.5.9 Foreign Reviews of Environmental Toxicology      
12.5.10 Foreign Reviews of Value      
12.7 Comprehensive Data Summaries      
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