11 regulatory assessment I Flashcards
what is the outline of this lecture?
governmental roles in pesticide regulations
-distribution of principal responsibilities
what are the governmental roles in pesticide regulations at the federal level?
PMRA
-PCPA and associated regulations
-registration and re-evaluation of pesticides
-human health and safety
-environmental impact
-value and efficacy
-alternative strategies
-compliance and enforcement
what are the governmental roles in pesticide regulations at the provincial/territorial level?
-prohibition (use restrictions) and permits
-transportation, sale, use, storage, disposal
-training, certification, licensing of applicators and vendors
-spills and incidents
-compliance and enforcement
what are the governmental roles in pesticide regulations at the municipal level?
-bylaws for municipal lands (e.g. parks, school grounds)
-some bylaws for private and residential lands only (e.g. lawn care)
what is the PRMA registration process (in detail)?
what is the screening of PRMA?
-division: submission coordination and documentation division
-purpose: make sure that submissions meet format, content and fee requirements of the agency before they are reviewed in detail
-to this end, the PRMA give industry pre-submission guidance on administrative procedures and data requirements
-a preliminary analysis of studies is carried out to see if they are acceptable and comply with international protocols
what is the reviews: (i) human health a) toxicological evaluation?
toxicological evaluation (hazard)
-main focus: how bad/toxic is the pesticide?
-here they identify possible health effects of pesticides and establish levels at which humans can be exposed without harm
-assessed through the evaluation of many different toxicological studies and associated dose-response relationships
-endpoints: carcinogenicity, genotoxicity, teratogenicity, etc.
-responsible for setting acceptable daily intakes (ADIs)
-ADIs always have safety factors built in
-ADI=the amount of a compound that can be consumed daily for a lifetime with no adverse effects
what is the reviews: (i) human health b) occupational exposure assessment?
-main focus: determine how much pesticide exposure could occur in a given day
-here they take into account different exposure levels for different people: people who work with pesticides vs bystanders, adults vs children
-this considers exposure from all sources (non-food related), including air and surfaces; indoor and outdoor settings; domestic, commercial and agricultural
-severity of endpoints from toxicological studies are also considered
-responsible for setting margins of exposure (MOE)
-MOEs of 100 to 1000 are typically required
-MOE=ratio of factors for a given population: NOAEL divided by predicted dose
what is the reviews: (i) human health c) food residue exposure assessment?
-main focus: how much pesticide exposure through food and drink can occur in a given day?
-only evaluates situations where products come into contact with food items
-dietary risk assessments are carried out to evaluate potential daily intake of pesticides from all possible food sources (aggregate exposure)-accounting for different eating patterns (age, ethnicity, etc)
-also considers cumulative effects
-responsible for setting maximum residue limits (MRLs) for both domestic and imported products
-MRL=the maximum amount of a pesticide that can remain on/in food products that will not be a long-term concern to human health
what is the reviews: (ii) environmental assessment a) environmental chemistry and fate?
-main focus: what happens to the pesticide once it enters the environment?
makes recommendations for restrictions that would lessen environmental risk. For example,
-buffer zones
-timing and frequency of application
-rate of application
what is the reviews: (ii) environmental assessment b) environmental toxicology?
-main focus: how toxic is the pesticide to all non-human organisms?
-here they establish levels at which different organisms (vertebrates, invertebrates, plants) can be exposed without significant harm
-assessed through the evaluation of many different toxicological studies with different species and associated dose-response relationships
-endpoints: survival, growth, reproduction, etc.
-responsible for setting NOECs (no observed effect concentrations)
what is review: (iii) laboratory services?
-evaluation of product chemistry data that accompanies submissions to ensure that the product is what it is supposed to be, and that there are no micro-contaminants
-also involved with misuse inspections
what is review: (iv) value and efficacy assessments?
-the applicant must experimentally verify that the product has merit and value for the purposes claimed when product is being used according to label directions
-assessment includes determining efficacy of the product at various doses
-this helps establish the lowest effective rate at which pesticides can be applied and contributes to minimizing risks to health, environment, crop damage and pest resistance problems
-these assessments have helped canadians have 50% lower label use rates that the same products in other countries
what are the decisions?
new products
-once all components of a submission are thoroughly reviews, the PRMA decides if a product should be granted registration
-registration is granted for 5 years, subject to renewal
-registrations can also be refused
registered products
-after a product is registered, the PRMA may re-evaluate it, resulting in changes to use patterns, label statements, or product classifications to ensure that risks are acceptable
-re-registrations can be refused
