Data Requirements for Import MRLs on Use Site Category (USC # 13): Terrestrial Feed Crops

Data Requirements for Import MRLs on Use Site Category (USC # 13): Terrestrial Feed Crops
Data Code Title Data required Conditions Present/
Absent
0 Index R    
1 Label R    
2 Chemistry requirements for the registration of a technical grade of active ingredient (TGAI) or an integrated system product.      
2.1 Applicant's Name and Office Address R    
2.2 Manufacturer's Name and Office Address and Manufacturing Plant's Name and Address R    
2.3 Product Trade Name R    
2.3.1 Other Names R    
2.4 Common Name R    
2.5 Chemical Name R    
2.6 Chemical Abstracts Registry Number R    
2.7 Structural Formula R    
2.8 Molecular Formula R    
2.9 Molecular Weight R    
2.10 Canadian Patent Status R    
2.11 Manufacturing Methods for the TGAI      
2.11.1 Manufacturing Summary R    
2.11.2 Description of Starting Materials R    
2.11.3 Detailed Production Process Description R    
2.11.4 Discussion of Formation of Impurities R    
2.12 Specifications      
2.12.1 Establishing Certified Limits CR A justification must be provided if standard limits are not met.  
2.12.2 Control Product Specification Form R    
2.13 Preliminary Analysis      
2.13.1 Methodology/Validation R    
2.13.2 Confirmation of Identity R    
2.13.3 Batch Data R    
2.13.4 Impurities of Toxicological Concern CR If applicable  
2.14 Chemical and Physical Properties      
2.14.1 Colour R    
2.14.2 Physical State R    
2.14.3 Odour R    
2.14.4 Melting Point / Melting Range R Solid at room temperature.  
2.14.5 Boiling Point / Boiling Range R Liquid at room temperature.  
2.14.6 Density or Specific Gravity R    
2.14.7 Water Solubility (mg/L) R    
2.14.8 Solvent Solubility (mg/L) R    
2.14.9 Vapor Pressure R    
2.14.10 Dissociation Constant R    
2.14.11 Octanol/Water Partition Coefficient R    
2.14.12 pH R    
2.14.13 UV/Visible Absorption Spectra R    
2.14.14 Stability (Sunlight, Temperature, Metals) R    
2.14.15 Storage Stability Data R Ambient 1 year may be submitted later but short term data is required  
2.15 Other Studies/Data/Reports/Foreign Reviews      
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 If heat is applied, or generated, or a chemical reaction takes place  
3.2.3 Discussion of the Formation of Impurities of Toxicological Concern CR If applicable.  
3.3 Specifications      
3.3.1 Establishing Certified Limits CR A justification must be provided if standard limits are not met.  
3.3.2 Additional Product Specific Requirements CR    
3.3.2.1 Granules and Baits CR If applicable.  
3.3.2.2 Seed Coatings CR If applicable.  
3.3.3 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 R    
3.5.2 Physical State R    
3.5.3 Odour R    
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 Ambient 1 year may be submitted later but short term data is required  
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 Other Studies/Data/Reports/Foreign Reviews      
4 Toxicology      
4.1 Summaries R    
4.2 Acute Studies - TGAI      
4.2.1 Acute Oral R    
4.2.2 Acute Dermal NR    
4.2.3 Acute Inhalation NR    
4.2.4 Primary Eye Irritation NR    
4.2.5 Primary Dermal Irritation NR    
4.2.6 Dermal Sensitization NR    
4.2.7 Potentiation/Interaction CR If available  
4.2.8 Antidote CR If available  
4.2.9 Other Acute Studies CR If available  
4.3 Short-term Studies - TGAI      
4.3.1 Short-term Oral (90-day rodent) R    
4.3.2 Short-term Oral (90-day and/or 12-month dog) R    
4.3.3 Short-term Oral (28-day) CR If available  
4.3.4 Short-term Dermal (90-day) NR    
4.3.5 Short-term Dermal (21/28-day) NR    
4.3.6 Short-term Inhalation (90-day) NR    
4.3.7 Short-term Inhalation (21/28-day) NR    
4.3.8 Other Short-term Studies CR If available  
4.4 Long-term Studies - TGAI      
4.4.1 Chronic (rodent) R 4.4.1 and 4.4.2 could be submitted as a combined study under 4.4.4  
4.4.2 Oncogenicity (rodent species 1) R 4.4.1 and 4.4.2 could be submitted as a combined study under 4.4.4  
4.4.3 Oncogenicity (rodent species 2) R    
4.4.4 Combined Chronic/Oncogenicity (rodent) CR 4.4.1 and 4.4.2 could be submitted as a combined study under 4.4.4  
4.4.5 Other Long-term Studies CR If available  
4.5 Special Studies - TGAI      
4.5.1 Multigeneration Reproduction (rodent) R    
4.5.2 Prenatal Developmental Toxicity (rodent) R    
4.5.3 Prenatal Developmental Toxicity (non-rodent) R    
4.5.4 Genotoxicity: Bacterial Reverse Mutation Assay R    
4.5.5 Genotoxicity: In vitro Mammalian Cell Assay R    
4.5.6 Genotoxicity: In vitro Mammalian Clastogenicity CR Required if not addressed in study submitted for 4.5.5  
4.5.7 Genotoxicity: In vivo Cytogenetics R    
4.5.8 Other Genotoxicity Studies CR If available  
4.5.9 Metabolism/Toxicokinetics in Mammals (laboratory animals) R    
4.5.10 Acute Delayed Neurotoxicity (hen) CR Required if the test substance is an organophosphorus substance or is structurally related to other substances that may cause delayed neurotoxicity  
4.5.11 28-day Delayed Neurotoxicity (hen) CR Required if results of acute delayed neurotoxicity study indicates effects, or if other available data indicate the potential for this type of delayed neurotoxicity  
4.5.12 Acute Neurotoxicity (rat) CR Required if there is neurotoxic potential  
4.5.13 90-day Neurotoxicity (rat) CR Required if there is neurotoxic potential  
4.5.14 Developmental Neurotoxicity CR Required if neurological effects are observed in other studies Should be considered if test substance:
i) causes neuropathology or neurotoxicity in adults;
ii) is hormonally active in vivo; or
iii) causes other types of nervous system involvement at a developmental stage
 
4.6 Acute Studies - EP      
4.6.1 Acute Oral CR If available  
4.6.2 Acute Dermal NR    
4.6.3 Acute Inhalation NR    
4.6.4 Primary Eye Irritation NR    
4.6.5 Primary Dermal Irritation NR    
4.6.6 Dermal Sensitization NR    
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) NR    
4.7.4 Short-term Dermal (21/28-day) NR    
4.7.5 Short-term Inhalation (21/28-day) NR    
4.7.6 Short-term Inhalation (90-day) NR    
4.7.7 Other Special Studies CR See 4.7  
4.8 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 R    
6.3 Plants R    
6.4 Other Studies/ Data/ Reports/ Foreign Reviews CR    
7 Food, Feed and Tobacco Residue Studies      
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    
7.3 Freezer Storage Stability Tests CR Depends on length of storage  
7.4 Crop Residue Data      
7.4.1 Supervised Residue Trial Study R    
7.4.2 Temporal Residue Trial Study CR Depends on size of crops  
7.4.3 Confined Crop Rotation Trial Study CR    
7.4.4 Field Crop Rotation Trial Study CR    
7.4.5 Processed Food/Feed CR    
7.4.6 Residue Data for Crops used as Livestock Feed R    
7.5 Livestock, Poultry, Egg and Milk Residue Data (from feeding of treated crops) CR    
7.8 Other Studies/ Data/ Reports/ Foreign Reviews CR    
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