Evaluation Templates

Evaluation templates are used to review the scientific studies that are submitted to support applications to register pest control products. These templates capture specific data components and record the reviewer's conclusions and rationales that are based on each data set. Executive summaries from templates are used to create an overall science monograph (i.e., review document) on which the regulatory decision is based.

Health Canada's Pest Management Regulatory Agency (PMRA) encourages that the evaluation templates be used by study directors during the preparation of the studies and the creation of their study reports. The level of detail, however, should be the same as would normally be included in a study report. Their early use provides significant benefits to PMRA evaluators and industry and result in consistency of content and format and the facilitation of the evaluation process.

Note: PMRA recognizes that the study and preparation period for a new pesticide submission can require a number of years. To facilitate the use of templates at the early stages of study development and report preparation, PMRA will accept draft or older versions of approved templates even if newer versions are available at the time of the actual submission to PMRA. The use and submission of draft or older templates will not exempt the submission from additional data requirements that are identified in the latest templates, regulations, etc. PMRA strongly recommends that Applicants check for and adopt new templates during the course of the preparation of a submission.

The templates can also be found on the United States Environmental Protection Agency's website.

Chemical Evaluation Template Categories

Chemistry Evaluation

• Streamlined OECD-format product chemistry evaluation report for a technical grade active ingredient or integrated system product
• Streamlined OECD-format product chemistry evaluation report for an end-use product or manufacturing concentrate
• NAFTA-format product chemistry evaluation report for a technical grade active ingredient or integrated system product
• NAFTA-format product chemistry evaluation report for a manufacturing concentrate or end-use product
• NAFTA-format evaluation report for analytical methodology in environmental media (parent compound and transformation products)

Efficacy Sustainability Assessment

• Efficacy: Laboratory, Growth Chamber Trials - Antifouling
• Efficacy: Laboratory, Growth Chamber Trials - Herbicides
• Efficacy: Laboratory, Growth Chamber Trials - Insecticide NonPP
• Efficacy: Laboratory, Growth Chamber Trials - Insecticide PP and Fungicide
• Efficacy: Laboratory, Growth Chamber Trials - Material Preservative
• Efficacy: Laboratory, Growth Chamber Trials - Water Treatment
• Efficacy: Laboratory, Growth Chamber Trials - Wood Preservative
• Efficacy: Small-scale Trials (Field, Greenhouse) Antifouling
• Efficacy: Small-scale Trials (Field, Greenhouse) Herbicides
• Efficacy: Small-scale Trials (Field, Greenhouse) Insecticide NonPP
• Efficacy: Small-scale Trials (Field, Greenhouse) Plant Protection Insecticides and Fungicides
• Efficacy: Small-scale Trials (Field, Greenhouse) Wood Preservative
• Efficacy: Operational Trials - Antimicrobial
• Efficacy: Operational Trials - Herbicides
• Efficacy: Operational Trials - Plant Protection Insecticide and Fungicide
• Efficacy: Operational Trials - Insecticide NonPP
• Efficacy: Operational Trials - Water
• Non-Safety Adverse Effects - Herbicides
• Non-Safety Adverse Effects - Plant Protection Insecticides and Fungicides
• Damage to Rotational Crops

Environmental Assessment

• Hydrolysis
• Phototransformation Soil
• Phototransformation Water
• Aerobic Soil 20°-30°C
• Aerobic Water 20°-30°C
• Aerobic Water/Sediment 20°-30°C
• Anaerobic Sediment/Water 20°-30°C
• Adsorption/Desorption
• Terrestrial Canada
• Terrestrial Northern United States
• Acute Toxicity: Earthworm
• Bees/Pollinators Acute Contact
• Bees/Pollinators Acute Oral
• Daphnia sp. Acute
• Daphnia sp. Chronic (Life-Cycle)
• Cold Water Fish (Rainbow Trout)
• Warm Water Fish (Bluegill Sunfish)
• Other Freshwater Fish Species
• Marine/Estuarine Fish
• Fish Early Life Cycle Toxicity Test
• Oral (LD50) Bobwhite Quail
• Oral (LD50) Mallard Duck
• Oral (LD50) Other Species
• Dietary (LC50) Bobwhite Quail
• Dietary (LC50) Mallard Duck
• Dietary (LC50) Other Species
• Avian Reproduction Bobwhite Quail
• Avian Reproduction Mallard Duck
• Avian Reproduction Other Species
• Fresh Water Algae
• Marine Algae
• Terrestrial Vascular Plants
• Aquatic Vascular Plants
• Laboratory Studies

Food Residue Exposure Assessment

PMRA developed updated Food Residue Chemistry Review Templates in collaboration with the Office of Pesticide Programs (OPP) at the United States Environmental Protection Agency (EPA). PMRA encourages registrants and applicants for registration to use the updated Food Residue Chemistry review templates for all their residue chemistry studies.

By promoting consistency, these templates will help PMRA evaluators in their review of submissions and reduce the time required to review the data package.

In addition, these templates will:

• increase efficiency and transparency;
• reduce workloads, thereby facilitating potentially faster release of decision documents;
• enable greater international harmonization of pesticide registrations;
• be an effective means of sharing information internationally, especially in joint international review of pesticide use submissions; and
• result in a resource savings that will benefit PMRA in multiple areas.

• Metabolism/Toxicokinetic Studies-Livestock (Livestock Metabolism Review Template)
• Metabolism/Toxicokinetic Studies-Plants (Plant Metabolism Review Template)
• Residue Trial Analytical Methodology - Plant and/or Animal Commodities (Residue Analytical Methods Review Template)
• Enforcement Analytical Methodology - Plant and/or Animal Commodities (Residue Analytical Methods Review Template)
• Inter-Laboratory Analytical Methodology Validation (Residue Analytical Methods Review Template)
• Extraction Efficiency (Residue Analytical Methods Review Template)
• Freezer Storage Stability Tests (Freezer Storage Stability in Livestock or Freezer Storage Stability in Plants Review Templates)
• Food and/or Feed Crop Residue Trial Study (Crop Residue Trial Review Template)
• Residue Decline Study (Crop Residue Trial Review Template)
• Confined Crop Rotational Trial Study (Confined Crop Rotation Review Template)
• Field Crop Rotational Trial Study (Field Accumulation Review Template)
• Processed Food/Feed (Processing Review Template)
• Animal Derived Commodities Residue Data (Livestock Feeding Review Template)

Occupational Exposure Assessment

• Use Description/Scenario (Application and Post Application)
• Pesticides Handlers Exposure Database Assessment (or other database)
• Mixer/Loader/Applicator: Passive Dosimetry Data
• Post Application: Passive Dosimetry Data Agricultural
• Post Application: Passive Dosimetry Data Residential
• Dermal Absorption (in vivo)
• Dislodgeable Residues (Foliar, Soil and Surface) Agricultural
• Dislodgeable Residues (Foliar, Soil and Surface) Turf
• Dislodgeable Residues (Foliar, Soil and Surface) Indoor Surface

Toxicology

• Acute Oral TGAI
• Acute Dermal TGAI
• Acute Inhalation TGAI
• Primary Eye Irritation TGAI
• Primary Dermal Irritation TGAI
• Dermal Sensitization TGAI
• Short-Term Oral (90 day) (rodent)
• Short-Term Oral (90 day and/or 12 month dog)
• Short-Term Oral (28 day)
• Short-Term Dermal (90 day)
• Short-Term Dermal (21 / 28 day)
• Short-Term Inhalation (90 day)
• Short-Term Inhalation (21 / 28 day)
• Other Short-Term Studies (Subchronic Oral Tox)
• Chronic (rodent)
• Oncogenicity (rodent species 1)
• Oncogenicity (rodent species 2)
• Combined Chronic/Oncogenicity (rodent)
• Multigeneration-Reproduction (rodent)
• Prenatal Developmental Toxicity (rodent)
• Prenatal Developmental Toxicity (non-rodent)
• Genotoxicity: Bacterial Reverse Mutation Assay
• Genotoxicity: In vitro Mammalian Cell Assay
• Genotoxicity: In vitro Mammalian Clastogenicity
• Genotoxicity: In vivo Cytogenetics
• Other Genotoxicity Studies
• Metabolism/Toxicokinetics in Mammals (laboratory animal)
• Acute Neurotoxicity (rat)
• 90 day Neurotoxicity (rat)
• Developmental Neurotoxicity Study - Rat
• Acute Oral EP
• Acute Dermal EP
• Acute Inhalation EP
• Primary Eye Irritation EP
• Primary Dermal Irritation EP
• Dermal Sensitization EP
• Short-Term Oral (90-day rodent)
• Short-Term Oral (90-day or 12-month dog)
• Short-Term Dermal (90-day)
• Short-Term Dermal (21/28-day)
• Short-Term Inhalation (21/28-day)
• Short-Term Inhalation (90-day)
• Subchronic Oral Toxicity
• Immunotoxicity EPA 880 3550
• Immunotoxicity EPA 870 7800
• Safety of Treated Animals

Microbial Evaluation Template Categories

Environmental Fate and Toxicology

• Aquatic Non-Arthropod Invertebrates
• Aquatic Plants and Algae
• Avian Oral
• Avian Pulmonary Inhalation or Injection
• Benthic Aquatic Arthropods
• Estuarine Fish
• Field Study
• Freshwater Fish
• Honey Bees
• Pelagic Aquatic Arthropods
• Terrestrial Arthropods
• Terrestrial Non-Arthropods Invertebrates
• Terrestrial Plants
• Wild Mammals

Human Health and Safety

• Acute Dermal Toxicity
• Acute Inhalation Toxicity
• Acute Oral Infectivity and Toxicity
• Acute Oral Toxicity
• Acute Pulmonary Infectivity and Toxicity
• Dermal Irritation
• Dermal Sensitization
• Eye Irritation
• Food and Feed Residue
• Genotoxic Potential
• Intraperitoneal Infectivity
• Intravenous or Subcutaneous Infectivity
• Occupational and Bystander Exposure
• Repeated Dose Inhalation Toxicity and Pathogenicity
• Reporting of Hypersensitivity Incidence
• Sensitivity of Detection
• Tissue Culture

Product Characterization and Analysis

• Product Characterization and Analysis