Aquaculture - End Use Products: Data Requirements for Use Site Category (USC # 1)

Aquaculture - End Use Products

Data Requirements for Use Site Category (USC # 1): Aquaculture - 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 and for EPs which expect to affect product efficacy  
3.5.2 Physical State R    
3.5.3 Odour CR Required for manufacturing concentrates and for EPs which expect to affect product efficacy  
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    
5.4 Mixer/Loader/Applicator- Passive Dosimetry Data R One of 5.4 or 5.5 is required  
5.5 Mixer/Loader/Applicator-Biological Monitoring Data R See above  
5.6 Post Application - Passive Dosimetry Data CR 5.6 or 5.7 may be required if there is potential for 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 if there is an inadequate margin of exposure  
5.13 Package Integrity Study CR Required if packaged in water soluble bags  
5.14 Other Studies/Data/Reports CR    
6 Metabolism/Toxicokinetics Studies (TGAI or EP)      
6.1 Summaries R    
6.2 Livestock - Fish/Shellfish CR Depending on aquatic system involved and if water/irrigated crops are fed to livestock; and if fish may be exposed to the pesticide or its degradation products  
6.3 Plants CR Depending on aquatic system and irrigated crop involved  
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 R    
7.4.2 Residue Decline Study R    
7.4.3 Confined Crop Rotation Trial Study R    
7.4.4 Field Crop Rotation Trial Study R    
7.4.5 Processed Food/Feed R    
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: Density or Specific Gravity (see Part 3 - EP) R Data submitted under 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 R    
8.2.4.6 Special Studies Related to Use-Pattern or Formulation CR Rate of release from treated surfaces is required for antifouling products  
8.3 Field Studies of Dissipation/Accumulation - May be Small- or Large-Scale      
8.3.1 Summary R    
8.3.2 Terrestrial      
8.3.2.1 Canada CR If there is a potential for soil exposure  
8.3.2.2 Northern U.S. CR Can substitute for some Canadian studies  
8.3.2.3 Other      
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 CR See 8.2.4.6 for rate of release from treated surfaces is required for antifouling products  
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 CR If there is a potential for freshwater exposure  
9.3.5 Laboratory Studies CR If there is a potential for exposure and
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 CR    
9.5.4 Laboratory Studies CR If there is a potential for exposure and
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 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 - TGAI R    
10.2.2 Description of Pest Problem      
  Identity of Pest R    
  Benefits/Need for Control of Pest CR Required if a new site-pest combination  
  Any Biological Aspect of Pest That Affect
Application Rates/Timing
CR Required if a new site-pest combination  
10.2.3 Efficacy Trials      
10.2.3.1 Summaries R    
10.2.3.2 Laboratory Trials (includes minimal effective dose) including test
protocol(s)
R One or both of 10.2.3.3 or 10.2.3.4 are
required
 
10.2.3.3 Small-scale Trials including test protocol(s) R See 10.2.3.2  
10.2.3.4 Operational Trials CR Large scale, often unreplicated operation use trials for which a research permit is usually required. Requirement to be determined at review.  
10.3 Adverse Effects on Use Site      
10.3.1 Summaries R    
10.3.2 Non-Safety Adverse Effects R Observation during efficacy trials that
there are no known adverse effects is
acceptable; Includes discoloration, corrosion, deposits, etc.
 
10.4 Economics CR Requirement determined at preliminary review  
10.5 Sustainability      
10.5.1 Survey of Alternatives (chemical and non-chemical) CR Requirement determined at preliminary review; Includes chemical or non-chemical alternatives  
10.5.2 Compatibility with Current Management Practices Including IPM 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    
12.5.6 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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