Bowerpoil. Pesticide Regulation in Canada. Mandate

Transcription

1 Bowerpoil 1*1 Pest Management Regulatory Agency Pesticide Regulation in Canada Coldstream Environmental Advisory Committee Yvonne Herbison Health Canada Pest Management Regulatory Agency Who We Are and What We Do Pesticide Registration Defining Risk Re-evaluation Reduced Risk / Low Risk '. ;ii!iidii - ifj« t I- Established in 1995 under Health Canada. Administers the Pesf Control Products Act which regulates the import, sale, packaging, manufacturing, distributing, labeling, and use of any substance that makes pest control claims. What is a Pesticide? The PCP Act defines a control product as: ''Any product, device, organism, substance, or thing that is manufactured, represented, sold or used as a means of directly or indirectly controlling, preventing, destroying, mitigating, attracting or repelling any pest." Mandate The mandate of the Agency is to protect health and environment by minimizing the risks associated with pesticides, while enabling access to pest management tools, namely, pest control products and sustainable pest management strategies. -Responsible for: regulation of pesticides at the national level health and environmental protection, value premarket assessment and re-evaluation of registered products proposing MRL's under Food and Drugs Act post-registration oversight - compliance, incident reporting, saies data sustainable pest management

2 6000 end use products and 550 active substances agriculture, forestry, rights of ways, domestic, structural, slimicides, material preservatives, wood preservatives, pool and spas, turf, domestic and ornamental product for homeowners... submissions and decisions: approx 3500/yr 25% agricultural products: submission and decisions Approximately 500 people work for Majority are scientists with advanced degrees in toxicology, environmental science, agricultural science, occupational exposure, biochemistry, chemistry etc. Decisions based on the latest scientific knowledge and standards Jsi, ^yss.sam' >?J? REGISTRATION Data is submitted to the Agency for review Scientists require months to evaluate a new data package which can include >200 studies Science review team writes a risk assessment Regulatory decision is made to register or reject Acute Toxicity Studies - "6 pack" Required for active ingredient & each end use product Health effects that may result from a single, high dose via various routes: Oral, dermal & inhalation Eye & skin irritation Dermal sensitization potential Used as the basis for precautionary label statements (eg., Caution - Poison or Danger- Poison) ** -.\P21 Metabolism Studies Absorption Distribution to tissues Metabolism Excretion Subchronic Studies Effects of repeat exposures (several weeks to 1 year) Various routes - oral, dermal, inhalation Various species - rat, rabbit, mouse, dog cross-species comparison characterizes toxicity at lower doses vs. acute studies "TT4

3 Chronic / Oncogenicity Studies Long-term effects, including cancer How: Rat (2 years) & mouse (18 months) - daily exposures Full tissue analysis - extensive data Genotoxicity / Mutagenicity Studies Assess potential pesticide interaction with DNA that could cause mutations or other damage Also used to determine cancer potential **.3'* wyw;.wl Reproductive Toxicity Assess effects on reproduction and offspring growth Determine if the young are more sensitive than adults How: Conducted over at least 2 generations Developmental Toxicity Effects on the developing fetus (birth defects) Assess potential for sensitivity in the young 'Critical study for evaluating potential endocrine effects &4 ' - "J?, >t Neurotoxicity Studies triggered for certain chemicals e.g. insecticide that shows signs of neurotoxicity in standard toxicity database Neurotoxic potential from single or repeated exposures in the adult Neurotoxic potential during development Evaluation of potential sensitivity in young animals vs adults Additional Studies Immunotoxicity May be required if possible indicators of impaired immune function are evident in chronic or subchronic studies Peer-reviewed published research Epidemiology studies (Human Health Studies) Published and unpublished (Industry) studies information considered in conjunction with ongoing reevaluation of pesticides, and for first-time registrations when available (e.g., use in other countries)

4 Reference Dose Determination Identify critical No Observed Adverse Effect Levels (NOAELs) Apply uncertainty factors: potential differences between humans and animals as the animal data is translated to humans (X 10) > Variations throughout population (X 10) Gaps in toxicity database (X 3-10) Environmental Evaluation -Environmental fate physical and chemical properties transformation processeffects of light, temp, and water mobility in soil and water Environmental toxicology establish lethal concentrations (LCs>) on lab animals establish no observed effect concentration NOEC effects on non-target species E&fci, Efficacy Data must show that the product controls the target pests Application rates at lowest appropriate frequency and rate Claims must be supported by test data Reliable pest control without damage to host or crop MRUs Maximum residue limit NOAEL - no observable adverse effect level 100 x safety factor or more ADI - acceptable daily intake Apply to residues on domestic and imported foods Import MRUs Food and Drug Act CFIA monitoring program Where do studies come from? Onus is on the applicant to submit all required studies (>2QQ studies for standard food crop use) Individual studies within a submission are often conducted by different independent laboratories] Studies must follow internationally developed and validated test guidelines for study protocols that adhere to "Good Laboratory Practices". Extensive data reporting allows scientists to conduct independent analyses of the raw data Published scientific literature - typically post-registraion is responsible for the registration of Pesticides in Canada M

5 Defining Risk "ffc. MriLim- S ^ ^ ^ ^ ^ ^ ^ ^ ^ V&*^ sa What is "Acceptable" Risk Acceptable risk: Reasonable certainty of no harm to health, future generations and environment from use or exposure when used according to label directions What is Risk and Risk Assessment? Purpose of health risk assessment for pesticides is to minimize the possibility of harm to human health One approach is to assure that the level of human exposure is well below the amount that could cause harm [As defined in PCPA s 2(2)]

6 Human Health Risk Assessment Hazard (toxicity) & exposure must be integrated to understand risk i\:'jk Assessment! Most substances have the potential to cause an adverse effect at high enough doses, but there is usuaiiy a lower dose where no harmful effect will occur Generally, as the amount of exposure increases, so does the risk of a toxic effect Health risk assessment puts a strong emphasis on determining both the amount and duration of people's exposure, including sensitive populations \.?&i vspsc? IP'S?-"; ' VMS^W-SflT^. -,3A~,.. ^r Exposure Levels and Risk determines the amount Canadians may be exposed to through diet and other activities These potential exposure levels are determined for various sensitive populations and age groups, including infants, toddlers, children, adolescents and adults Potential exposure is overestimated for protection registers only those uses where human exposure are well below a level that is non-toxic - at least 10Ox lower Aggregate Risk Assessment All exposures that co-occur for one pesticide are incorporated into a single risk estimate. Drinking water Food Occupational Exposure during and after application for domestic or commercial products used in a residential setting - includes golf courses, schools, etc. All routes: oral, dermal, inhalation ts&l-ji rs-4. TJ3*--yA r - Cumulative Risk Assessment Combined exposure/risk for a group of pesticides that share a common mechanism of toxicity (eg., organophosphates, specific carbamates) Re-evaluation In 2000, committed to review 401 pesticide active ingredients registered prior to % have been addressed (Sept 2008) Target date for completion is end of 2009 Re-evaluation follows a 15 year cycle from when a given pesticide is first registered (as per PCPA)

7 Variations Microbiais (eg., Bt for Gypsy moth) Pheromones (Verbenone - mountain pine beetle) Biochemicals and non-conventiona! pesticides (eg., Soap salts, acetic acid ) Reduced Risk, Low Risk and Non- Conventional Pesticide Registrations Reduced Risk is relative and not necessarily low risk Low Risk - Biochemical and Non-Conventional A separate registration framework where data requirements are flexible to fit the risk Registration requirements will be decided on a case by case basis Must be - Lowtoxicity - Not persistent - No significant human or environmental exposure - Widely available, not likely to cause resistance, no residue of concern ^ 9. i-m'.. ; " "». - ; > ^^^^^^^^S^^^^^^^^M^S New Pesticide Registrations Number of Actives Registered bytype Now Actives First Appearing In Registered Products ^ Sarritor PCP Commercial PCP Domestic ^hemicats Scieroiinia minor Herbicide registered for the suppression of dandelion top growth in of dandelion Very temperature dependant re efficacy- optimum 18-24c, not above 27c Recommend keep frozen or refrigerated and note shelf life Must be irrigated ia " " : o. " :.-. 7, SARRITOR Serenade " t* "- * i*. V " " "' >' ';> Serenade MAX PCP commercial wettable powder Serenade ASO PCP28626 commercial aqueous suspension Serenade Garden PCP domestic concentrate Serenade Garden PCP domestic ready to use I 'm. W*- *" # * 1 - i» ' ' m "mu % "r **/*" ' : ' & " :. ' ' :. - ;- :. " *.. - ' *»/;*-.. \ -' «- -. i" i..li Ji ' Bacillus subtilis Botrytis, mildew, sour rot, fire blight, apple scab Domestic products have some ornamentals such as roses, phlox but not the pome fruit Commercial products have large label including, grape, pome fruit, strawberries, raspberries and many vegetables PHI 0 days " _ J. -