Data Requirements for Use Site Category (USC # 12): Stored Food and Feed - End Use Products

Data Requirements for Use Site Category (USC # 12): Stored Food and Feed - 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  
5.6 Post Application - Passive Dosimetry Data CR 5.6 or 5.7 may be required if there is potential post-application exposure  
5.7 Post Application - Biological Monitoring Data CR See 5.6  
5.8 Dermal Absorption (in vivo) CR Required if margin of exposure is inadequate  
5.11 Glove/Clothing Penetration Data CR May be required for risk mitigation purposes or for inadequate margin of exposure  
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    
6.2 Livestock CR Depends on petitioned use and crops  
6.3 Plant R    
6.4 Other Studies/Data/Reports CR If available  
7 Food, Feed and Tobacco Residue Studies      
7.1 Summaries R    
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 If stored for more than 30 days and/or volatile or labile study required  
7.4 Crop Residue Data      
7.4.1 Supervised Residue Trial Study CR    
7.4.2 Residue Decline Study CR Depends on results of 7.4.1  
7.4.5 Processed Food/Feed CR Depends on the processed commodities and practices  
7.4.6 Residue Data for Crops used as Livestock Feed (if needed for forage crops) CR Depends on petitioned uses and crops  
7.5 Livestock, Poultry, Egg and Milk Residue Data (from feeding of treated crops) CR Depends on petitioned uses and crops  
7.6 Livestock, Poultry, Egg and Milk Residue Data (external application)      
7.7 Tobacco Residue Data (if residues are found on cured tobacco leaves) CR Depends on label directions  
7.8 Other Studies/Data/Reports CR If available  
7.8.1 Other Studies/Pyrolysis Study R Pyrolysis studies on cigarettes manufactured from treated leaves are required if tobacco residues >0.1 ppm  
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 CR If there is a potential for soil exposure  
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    
8.3.2 Terrestrial      
8.3.2.1 Canada CR    
8.3.2.2 Northern U.S. CR Can substitute for Canadian studies, if they are required  
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 CR    
9.2 Non-Target Terrestrial Invertebrates      
9.2.1 Summaries CR    
9.3 Non-Target Freshwater Invertebrates      
9.3.1 Summary CR If there is a potential for freshwater exposure  
9.4 Non-Target Marine Invertebrates      
9.4.1 Summary CR If there is a potential for estuarine/marine exposure  
9.5 Fish      
9.5.1 Summaries CR If there is a potential for exposure  
9.6 Wild Birds      
9.6.1 Summary CR If there is a potential for exposure  
9.6.6 Special Studies Related to the Intended Use-Pattern (TGAI and EP) CR Acute inhalation (LD50) with bobwhite quail or mallard duck, if there is a potential for avian exposure  
9.8 Non-Target Plants      
9.8.1 Summary CR    
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 CR    
10.2.3.3 Efficacy: Small-scale Trials (storage facility) CR    
10.2.3.4 Efficacy: Operational Trials CR    
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.] 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 CR    
10.5.3 Resistance Management R    
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 CR    
12.5.4 Foreign Reviews of Toxicology CR    
12.5.5 Foreign Reviews of Exposure (Occupational and/or Bystander) CR    
12.5.6 Foreign Reviews of Metabolism / Toxicokinetics Studies CR    
12.5.7 Foreign Reviews of Food, Feed and Tobacco Residue Studies 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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