Data Requirements for Use Site Category (USC # 17): Industrial Process Fluids - End Use Products

Data Requirements for Use Site Category ( USC # 17): Industrial Process Fluids - 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    
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    
5.3 Pesticides Handlers Exposure Database Assessment (or other database) R One of 5.3, 5.4 or 5.5 is required  
5.4 Mixer/Loader/Applicator- Passive Dosimetry Data R See 5.3  
5.5 Mixer/Loader/Applicator-Biological Monitoring Data R See 5.3  
5.8 Dermal Absorption CR Required if the margin of safety is inadequate  
5.11 Glove/Clothing Penetration Data CR May be required for risk mitigation purposes or for an inadequate margin of safety  
5.13 Package Integrity Study CR Required if packaged in water soluble bags  
5.14 Other Studies/Data/Reports CR If available  
8 Environmental Chemistry and Fate      
8.1 Summaries R    
8.2 Laboratory Studies      
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 R    
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 CR    
8.3.3 Aquatic      
8.3.3.1 Canada CR Based on potential for aquatic exposure and if pesticide residues have the potential for persistence, mobility, non-target aquatic toxicity or bioaccumulation  
8.3.3.2 Northern U.S. CR Can augment Canadian studies  
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 and EP)      
8.4.1 Summary R    
8.5 Other Environmental Fate Studies (TGAI and 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 R    
9.3 Non-Target Freshwater Invertebrates      
9.3.1 Summary R    
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  
9.4 Non-Target Marine Invertebrates      
9.4.1 Summary CR If there is a potential for estuarine/marine exposure  
9.4.6 Laboratory Studies CR If there is a potential for exposure and components of the EP are of concern  
9.4.7 Field Studies CR Based on concerns arising from results of other studies  
9.5 Fish      
9.5.1 Summaries R    
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 R    
9.6.4 Laboratory Studies CR If there is a potential for exposure and components of the EP 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 R    
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      
  Identity of Pest R    
  Benefits/Need for Control of Pest CR Required if a new site or pest  
  Any Biological Aspects of Pest That Affect Application Rates/Timing CR Required if a new site or pest  
10.2.3 Efficacy Trials      
10.2.3.1 Summaries R    
10.2.3.2 Laboratory Trials (demonstrates inherent antimicrobial properties) R Can be conducted as preliminary work for operational/small scale trial  
10.2.3.3 Small Scale Trial simulating actual use R May be waived if oprational trial conducted  
10.2.3.4 Operational Trials R May be waived if small scale trial conducted  
10.3 Adverse Effects on Use Site      
10.3.1 Summaries R    
10.3.2 Non-Safety Adverse Effects R    
10.4 Economics CR Requirement determined at preliminary review  
10.5 Sustainability      
10.5.1 Survey of Alternatives (chemical and non-chemical) R Required on chemical or non chemical alternatives for all new actives, uses or pests. Requirement determined at preliminary review  
10.5.2 Compatibility with Current Management Practices CR Requirement determined at preliminary review  
10.5.3 Resistance Management CR Requirement determined at preliminary review  
10.5.4 Contribution to Risk Reduction CR Requirement determined at preliminary review  
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 CR    
12.5.4 Foreign Reviews of Toxicology CR    
12.5.5 Foreign Reviews of Exposure (Occupational and/or Bystander) CR    
12.5.8 Foreign Reviews of Environmental Chemistry and Fate CR    
12.5.9 Foreign Reviews of Environmental Toxicology CR    
12.5.10 Foreign Reviews of Value CR    
12.7 Comprehensive Data Summaries R    
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