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