Underwater Structures and Materials - End Use Products: Data Requirements for Use Site Category (USC # 22):

Underwater Structures and Materials - End Use Products

Data Requirements for Use Site Category ( USC # 22): Underwater Structures and Materials - 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    
5.3 Pesticides Handlers Exposure Database Assessment (or other database) R One of 5.3, 5.4 or 5.5  
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 May be required if the margin of safety is inadequate  
5.11 Glove/Clothing Penetration Data CR May be required for risk mitigation purposes and 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  
6 Metabolism/Toxicokinetics Studies (TGAI or EP)      
6.1 Summaries R Input to assessment of toxicity to wildlife  
6.2 Livestock (Fish) R Peer review of toxicology review  
6.3 Plants      
6.4 Other Studies/Data/Reports CR If available  
7 Food, Feed and Tobacco Residue Studies EP      
7.1 Summaries R Input to assessment of wildlife exposure  
7.2 Analytical Methodology (Food Crops & Tobacco)      
7.2.1 Supervised Residue Trial Analytical Methodology R    
7.2.2 Enforcement Analytical Methodology R    
7.2.3 Inter-laboratory Analytical Methodology Validation R    
7.2.4 Multi-residue Analytical Methodology Evaluation R    
7.2.5 Storage Stability of Working Solutions in Analytical Methodology R    
7.3 Freezer Storage Stability Tests CR Depends on the length of storage  
7.4 Crop Residue Data      
7.4.1 Supervised Residue Trial Study      
7.4.2 Residue Decline Study CR Depends on size of crop  
7.4.3 Confined Crop Rotation Trial Study      
7.4.4 Field Crop Rotation Trial Study      
7.4.5 Processed Food/Feed CR    
7.4.6 Residue Data for Crops used as Livestock Feed (if needed in forage crops)      
7.5 Livestock, Poultry, Egg and Milk Residue Data (from feeding of treated crops)      
7.6 Livestock, Poultry, Egg and Milk Residue Data (external application)      
7.8 Other Studies/Data/Reports CR If available  
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      
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 R Rate of release from treated surface  
8.3 Field Studies of Dissipation/ Accumulation [May be Small- or Large-Scale]      
8.3.1 Summary R    
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  
8.3.3.3 Other      
8.3.4 Special Studies Related to Intended Use Pattern R See 8.2.4.6 for rate of release from treated surface  
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    
8.5.2 Incineration - thermal decomposition at high and low temperatures      
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 with End-Use product 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 R    
9.4.6 Laboratory Studies with End-Use product CR If 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 with End-Use product 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 with End-Use product CR If 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 or 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 with End-Use product 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 R 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    
10.3.3 Damage to Rotational Crops CR    
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)      
12.5.6 Foreign Reviews of Metabolism / Toxicokinetics Studies      
12.5.7 Foreign Reviews of Food, Feed and Tobacco Residue Studies      
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      
Report a problem or mistake on this page
Please select all that apply:

Thank you for your help!

You will not receive a reply. For enquiries, contact us.

Date modified: