3b. Envir Ris Eng

Environmental Risk
Assessment
Janice Villeneuve
Senior Evaluation Officer, Re-evaluation Section 1
Environmental Assessment Directorate
Canadian Pesticide Regulation Course
February 27-28, 2008
Overview
• Purpose of Environmental Risk Assessment

• Data Requirements
• Low-Risk
• Risk Assessment Framework
• Exposure Assessment
• Hazard Assessment
• Risk Characterization
• Risk Mitigation Measures
• Drinking Water Estimates
• Toxic Substances Management Policy
• Common Deficiencies
• Environmental Case Study
2
Purpose of Environmental Risk

Assessment
• Evaluate the likelihood that adverse environmental
effects may occur or are occurring as a result of
exposure to the pesticide (active ingredients and
transformation products)
• Determine whether changes to the use or proposed
use of that pesticide are necessary to protect the
environment
3
Data Requirements
• USC DACO Tables

• Total of 33 different USCs
• “CR” – conditional on the potential for exposure
• Most agricultural pesticides require the studies listed
under Use-site Category 14 (USC14)
• For some USCs, the data requirements are reduced
because the potential for exposure is reduced
4
Low-Risk
• Risk assessment methods are the same

• Data requirements may be reduced based on toxicity
and exposure information
5
Risk Assessment Framework
Exposure Assessment Hazard Assessment
Risk Characterization
Risk Mitigation
Options
6
Environmental Exposure Assessment
• Estimates the potential exposure of plants and

animals to pesticide residues in water, food, soil and
air.
• Includes information on how often, how long and the
amount of pesticide to which an organism may be
exposed.
• Based on environmental fate and transport data as
well as modeling and field monitoring information.
7
Studies to Estimate Exposure
• Physicochemical properties
• Solubility, vapour pressure, Kow, pKa, UV-absorption
• Transformation (Abiotic and Biotic)
• Hydrolysis, phototransformation, aerobic/anaerobic
biotransformation (terrestrial and aquatic)
• Mobility
• Leaching, volatilization
• Field dissipation (DIR2006-01)
• Fate and mobility in sites representative of use areas in Canada
• Guideline for Determining Environmental Chemistry and Fate (T-1-225)

• Harmonization of Environmental Chemistry and Fate Data (DIR2003-03)
8
Environmental Hazard Assessment
• Describes the types of effects a pesticide can

produce in organisms and how those effects change
with varying pesticide exposure levels
• Based on accepted protocols with surrogate test
species
• Determines effects endpoints and dose response
(e.g. LD50, NOEC, EC25)
• Identify sensitive organisms and predicts adverse
effect(s) on non-target organisms.
9
Terrestrial Species Typically Studied
• Earthworm
• Honeybee
• Beneficial Insects
• parasitic wasp, predatory mite, ladybird beetle, lacewing, minute
pirate bug, ground beetle
• Birds (Acute and Reproduction)
• mallard duck
• bobwhite quail
• Mammals (Acute and Reproduction)
• rats, mice (reviewed by HED)
• Terrestrial vascular plants
10
Aquatic Species Typically Studied –

Freshwater
• Invertebrates (acute and reproduction)
• Daphnia magna
• Fish (acute, early-life stage, life-cycle)
• rainbow trout
• bluegill sunfish
• Algae (acute): 3 species
• Selenastrum capricornutum
• Anabaena sp.
• diatom
• Vascular plant
• Lemna gibba
11
Aquatic Species Typically Studied –

Estuarine/Marine
• Crustacean (Acute and chronic)
• mysid
• Mollusk embryo larvae OR shell deposition
• Fish (acute and chronic)
• sheepshead minnow
• Algae (acute)
12
• Compare the levels of exposure (estimated

environmental concentrations - EEC) expected in the
environment according to the proposed or actual use
pattern to those levels that produce toxic effects in
laboratory and field studies
• When EEC exceeds levels expected to cause effects
(level of concern - LOC), measures to mitigate the
risk are examined
13
Risk Characterization –
Screening vs. Refined
• Screening Level Risk Assessment
• Goal to identify:
– Pesticides that do not pose a concern
– Group(s) of organisms that would not be at risk
– Pesticides that have a potential for concern, and risk
needs further characterization
• Based on conservative scenarios, simple methods
• Refined Risk Assessment
• Goal: further characterize the risk using more refined
scenarios
• Tiers of refinement to adequately characterize risk
14
• Deterministic Method
• Risk Quotient (RQ) = Exposure/Toxicity
• RQ ≤ 1: Negligible Concern
• RQ > 1: Potential for Concern
• Probabilistic Methods
• Refined risk assessment
• Only if sufficient data are available
• Re-evaluation
15
Risk Characterization –
Terrestrial (Effects Endpoints used)
• Earthworms
• LC50 x 0.5 or NOEC
• Beneficial Insects
• LR50
• Birds/Mammals
• Acute oral LD50 x 0.1 OR NOEL
• Dietary LC50 x 0.1 OR NOEC
• Reproduction NOEC
• Vascular Plants
• EC25 for most sensitive plant species (seedling emergence or
vegetative vigour)
16
Estimated Environmental Concentrations

(EECs) – Terrestrial
• Screening Level
• Soil: g a.i./kg soil
• Application rate: g a.i./ha (beneficial insects/plants)
• Food Sources: g a.i./kg diet
– Dosages consumed in contaminated food items
estimated using Hoerger and Kenaga (1972) nomogram
and modification by Fletcher et al (1994)
• Inhalation: concentration in air
– Modelling data – estimated air concentrations
– Monitoring data – measured air concentrations
17
Risk Characterization – Terrestrial

Screening Level
• Integrate Exposure and Effect to identify risk using
RQ method for all terrestrial organism groups
• Risk Quotient (RQ) = Exposure/Toxicity
• RQ ≤ 1: Negligible Concern
• RQ > 1: Potential for Concern (proceed to refined risk
assessment)
18
Risk Characterization – Terrestrial

Options for Refinement
• More realistic exposure scenario
• Use pattern
• Fate/persistence information
• Consideration of off-target effects from spray drift
• Specific scenarios
• Crop-specific scenarios, relevant species, species-specific diets,
behaviour of species
• Additional options for Registered Products/Re-evaluation
• Additional effects endpoints
• Data from research and monitoring
• Incident Reports
• Probabilistic risk assessments
19
Risk Characterization – Aquatic

Endpoints Used Effects
• Aquatic plants/Pelagic invertebrates/Benthic invertebrates
• Acute: EC50 x 0.5
• Chronic: NOEC
• Fish
• Acute: LC50 x 0.1
• Chronic: NOEC
• Amphibians (aquatic stages) – use fish endpoints when no
amphibian data are available
• Acute: LC50 x 0.1
• Chronic: NOEC
20

EECs
• Screening Level Assessment
• Water: g a.i./L (15 cm forestry uses, 15 cm seasonal water
body, 80 cm permanent water body)
– Conservative assumptions: maximum seasonal rate,
shortest application interval, adjust for transformation for
multiple applications, direct application
• Refined Assessment
• Run off: PRZM/EXAMS
– Appropriate scenarios are run based on the use pattern
identified
• Drift: EECs resulting from spray drift using the maximum drift
deposition for application method
21
Maximum Drift Deposition Table
Maximum Spray Drift Deposition % Drift at 1 m downwind

Mode of Application Spray Quality (ASAE) Drift (% of applied)
Ground Boom Sprayer Coarse 3%
Ground Boom Sprayer Medium 6%
Ground Boom Sprayer Fine 11%
Airblast - Early Season Fine 74%
Airblast - Late Season Fine 59%
Aerial - Agricultural Crops Coarse 17%
Aerial - Agricultural Crops Medium 23%
Aerial - Agricultural Crops Fine 26%
Aerial - Non-Crops Coarse 60%
Aerial - Non-Crops Medium 60%
Aerial - Non-Crops Fine 44%
Aerial - Forestry Coarse 77%
Aerial - Forestry Medium 85%
Aerial - Forestry Fine 90%
Note: RQs should be calculated for all uses on the label in order to characterize the risk..
For field and aerial applications use a Fine and Medium droplet sizes for insecticides and herbicides,
respectively, unless otherwise stated on the label
22

Screening Level
• Screening level assessment
• RQ ≤ 1 – no further refinement required
• RQ > 1 – potential concern, proceed to refined assessment
23

Refined
• Refined risk assessment
• Drift
– If RQ ≤ 1 – default buffer zone of 1 m will be assigned
– If RQ > 1 – appropriate buffer zones will be determined
 Aerial – AgDISP v.8.15 (2005)
 Ground – Wolf and Caldwell (2001)
 Ground – Airblast – Ganzelmeier et al (1995)
• Run off
– EECs predicted by PRZM-EXAMS
 If RQ ≤ 1 – no risk identified for run off
 If RQ > 1 – potential risk identified for run off; consider
further refinements – identify risk mitigation measures
24

Additional Options for Refinement
• Further refinement to modelling inputs to represent
more realistic scenarios
• Other options where sufficient data is available –
registered products/re-evaluation
• Additional toxicity endpoints – species sensitivity
distributions
• Monitoring data/incident reports
• Probabilistic risk assessment
25
Risk Mitigation Measures - Examples
• Reduce number of applications per season

• Buffer zones to reduce drift to non-target species/sensitive areas
• Restrict against applications in consecutive years
• Restrict to ground application (no aerial use)
• Use decreased application rates (determined in conjunction with
efficacy review)
• Change application conditions (time of day)
• Choose certain formulation types
• Require immediate incorporation in soil
• Restriction of certain uses or entire active ingredient
• Label advisory statements
26
Some Areas Requiring Further

Development
• Improved RA methods for birds, mammals and
terrestrial plants – currently investigating
• Probabilistic risk assessment – has been used for
re-evaluation
27
Drinking Water Estimates for Human

Health Assessment
• Drinking water estimates for use in the human health
assessment are determined by EAD
• PRZM/EXAMS - EEC in drinking water from surface run off
• LEACHM - EEC in drinking water from groundwater sources
• When sufficient water monitoring data are available, these
data are considered in the estimate of drinking water
exposure
• SPN2004-01 (Estimating the Water Component of a
Dietary Exposure Assessment)
28
Toxic Substances Management Policy

(DIR99-03)
• Assesses if active ingredient, transformation product
or any other substance within a product are classified
as Track 1
• Track 1
– CEPA-toxic or equivalent, predominantly anthropogenic,
persistent and bioaccumulative
– Virtual elimination
• Track 2
– Does not meet all of the criteria for Track 1
– Full life-cycle management
29
Environmental Risk Assessment – Case

Study
Spiromesifen
Major transformation product: BSN 2060-enol
30
Physicochemical Properties
Property Value Interpretation
Water solubility 0.13 mg/L Sparingly soluble
Vapour pressure 1 x 10-6 Pa Not volatile
Henry’s law 1.9 x 10-7 atm Not likely to volatilize from
constant m3/mol water or moist soil
n-Octanol–water Potential for
4.55
coefficient bioaccumulation
Dissociation No pKa between Unlikely to be mobile at
constant pH 4 and 9 ambient pH
λmax = 214 nm Phototransformation in
UV-vis adsorption
the environment unlikely
31
Abiotic Transformation: Parent
• Hydrolysis
• Half-life: pH 4 = 48 d; pH 7 = 26 d; pH 9 = 4.5 d
– Not an important route of transformation at pH 4 and 7,
but importance increases under basic conditions
• Soil phototransformation
• Half-life: 47.2 d
– Not an important route of transformation
• Water phototransformation
• Half-life: 3.6 h
– An important route of transformation
32
Biotransformation: Parent
• Soil: half-life: 2.8–18 d

• Non-persistent to moderately persistent, depending on soil
characteristics
• Water:
• Aerobic half-life: 4.1–8 d
– Non-persistent to slightly persistent
• Anaerobic half-life: 18 d
– Slightly persistent
• Bioaccumulation: BCF 875 – 916
• Bioaccumulates but readily depurated – bioaccumulation is
not a concern
33
Field Dissipation – Parent
• Terrestrial field dissipation

• DT50 = 4.5 d
• Parent is non-persistent under field conditions
34
Data submitted for transformation

product: BSN 2060-enol
• Water phototransformation
• Half-life: 16.5 d
– Not an important route of transformation
• Adsorption/desorption
• Kd = 0.0185–0.049 mL/g
– Very highly mobile
• Field dissipation
• DT50 = 18 d
– Slightly persistent
35
Overall Conclusion – Persistence
• Parent
• Terrestrial – non-persistent
• Aquatic – non-persistent to slightly persistent
• Transformation product
• Terrestrial – slightly persistent
• Aquatic – slightly to moderately persistent
36
Mobility – Parent
• Adsorption-desorption – parent was not stable in

CaCl2; therefore, study could not be conducted
• Soil leaching – unaged soil
• Parent remained in top soil layer - not mobile
• Soil TLC – Rf = 0.0021 – parent is immobile
• Overall conclusions considering log Kow, pKa, and

mobility studies – parent is not mobile in soil;
transformation product is very highly mobile
37
Screening Level Risk Assessment –

Terrestrial Invertebrates
Organisms Study Substance RQ > LOC
Carabid beetle Contact EUP 1.11 Yes
Ladybird Contact EUP 17.5 Yes
Predaceous mite Contact EUP 11.3 Yes
Aphid Contact EUP 74.7 Yes
• LOC was not exceeded for earthworm, honeybee, rove beetle,

green lacewing
38
Refined Risk Assessment –

Terrestrial Invertebrates
Organisms Refined RQ > LOC Mitigation
(10 d foliar t½)
Carabid 0.84 No
Ladybird 13.3 Yes Label advisory
statement
Predaceous mite 8.6 Yes
Aphid 56.6 Yes
39
Screening Risk Assessment –

Terrestrial Vertebrates
Organisms Study Substance RQ > LOC
Bird Acute Oral Parent 0.017 No
Dietary Parent 0.03 No
Repro Parent 1.7 Yes
Small Mammal Acute Oral Parent 0.46 No
Dietary 28 d Parent 3.7 Yes
Dietary 90 d Parent 3.7 Yes
Repro Parent 3.1 Yes
40

Terrestrial Vertebrates
Organisms Refined RQ (10 d > LOC Mitigation
half-life on plants)
Birds – repro 1.29 Yes The persistence of
spiromesifen is low in the
Mammals – dietary 2.8 Yes environment; therefore, it is
Mammals – repro 2.3 Yes unlikely that birds or
mammals will be exposed
chronically.
41
Screening Risk Assessment –

Terrestrial Plants
Organism Study Substance RQ > LOC Mitigation
Vascular Seedling EUP 30.9 Yes Buffer zones

plants Emergence 14.6 Yes for terrestrial
and Vegetative habitats
Vigour 14.6 Yes
42

Aquatic Invertebrates
Organism Exposure Substance RQ > LOC
FW Invert Acute Parent 1.8 Yes
EUP 0.009 No
enol TP 0.002 No
Chronic Parent 324 Yes
EUP 47.6 Yes
enol TP 0.435 No
Chronic pop’n study EUP 144.6 Yes
43

Aquatic Invertebrates
Organism Substance Drift/Run off RQ > LOC Mitigation
FW Invert Parent Drift 0.19 No Buffer zones considered
Run off 0.011 No
EUP Drift 5.24 Yes
EUP Drift 15.9 Yes
E-M Invert Parent Drift 0.23 No Not required
Run off 0.49 No
44
Screening Level Assessment –

Aquatic Fish/Amphibians
Organisms Exposure Substance RQ > LOC
FW Fish Acute Parent 48.2 Yes
EUP 11.1 Yes
TP 0.008 No
EM Fish Acute Parent 17.5 Yes
Amphibians (based on Acute Parent 256 Yes
fish endpoint; 15 cm TP 0.04 No
water body)
45

Aquatic Fish/Amphibians
Organisms Exposure Drift/Run off RQ >LOC Mitigation
FW Fish Acute Drift 5.3 Yes Buffer zone considered
Chronic Drift 5.9 Yes Chronic exposure not expected
due to chemical properties
Acute Run off 0.3 No Not required
Chronic Run off 0.02 No
EM Fish Acute Drift 1.9 Yes Buffer zone considered
Run off 0.1 No Not required
Amphibians Acute Drift 28.2 Yes Buffer zone considered
Chronic Drift 31.5 Yes Chronic exposure not expected
due to chemical properties
Acute Run off 0.3 No Not required
Chronic Run off 0.06 No
46

Aquatic Plants
Organisms Exposure Substance RQ > LOC
FW algae Acute Parent 3.6 Yes
TP 10.9 Yes
Vascular plants Acute Parent 1.6 Yes
47

Aquatic Plants
Organisms Substance Drift/Run off RQ > LOC Mitigation
FW algae Parent Drift 0.4 No Not required
TP 1.2 Yes Buffer zone
considered
Parent Run off 0.02 No Not required
TP 221 Yes Label advisory
statement
Vascular Parent Drift 0.18 No Not required
plants
Run off 0.01 No
48
Overall Environmental Mitigation

Measures
• Buffer Zones
• Ground
– 2 to 10 m for freshwater habitats
– 1 m for marine habitats
– 1 to 2 m for terrestrial habitats
• Aerial
– 25 to 350 m for freshwater habitats
– 1 to 10 m for marine habitats
– 40 to 45 m for terrestrial habitats
• Toxicity and run off advisory statements
49
Common Deficiencies/Problems
• Studies often not submitted

• DACO 8.2.3.4.4 – anaerobic soil (only required for USC 14)
• Oral bee study
• General information on TPs (Kow, solubility, etc.)
• Problems with studies
• Fate studies
– Major transformation products not identified
– Studies cut too short – does not allow for determination of TP half-lives
– Improper sampling periods
– Inappropriate extraction and analytical methods
– Desorption not performed using 3 consecutive desorption cycles (as per
T-1-255)
• Toxicity studies (aquatic)
– Studies conducted above solubility of compound
• Link in submitted studies/templates to raw data in Excel format
50
Reference Documents
• USC DACO Tables

(www.pmra-arla.gc.ca/english/appregis/daco-e.html)
• PRO2007-02
(www.pmra-arla.gc.ca/english/pdf/pro/pro2007-02-e.pdf)
• T-1-255
(www.pmra-arla.gc.ca/english/pdf/dir/dir_t1255-e.pdf)
• DIR2006-01
(www.pmra-arla.gc.ca/english/pdf/dir/dir2006-01-e.pdf)
• DIR2003-03
(www.pmra-arla.gc.ca/english/pdf/dir/dir2003-03-e.pdf)
51
Reference Documents (cont’d)
• Pesticide Incident Reporting

(www.pmra-arla.gc.ca/english/legis/aer-e.html)
• PRO2005-06
(www.pmra-arla.gc.ca/english/pdf/pro/pro2005-06-e.pdf)
• SPN2004-01
(www.pmra-arla.gc.ca/english/pdf/spn/spn2004-01-e.pdf)
• DIR99-03
(www.pmra-arla.gc.ca/english/pdf/dir/dir9903-e.pdf)
52
Questions
?
53

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Environmental Risk

• Purpose of Environmental Risk Assessment

Purpose of Environmental Risk

• USC DACO Tables

• Risk assessment methods are the same

Risk Assessment Framework

Exposure Assessment Hazard Assessment

Environmental Exposure Assessment

• Estimates the potential exposure of plants and

Studies to Estimate Exposure

• Guideline for Determining Environmental Chemistry and Fate (T-1-225)

Environmental Hazard Assessment

• Describes the types of effects a pesticide can

Terrestrial Species Typically Studied

Aquatic Species Typically Studied –

Aquatic Species Typically Studied –

• Compare the levels of exposure (estimated

Estimated Environmental Concentrations

Risk Characterization – Terrestrial

Risk Characterization – Terrestrial

Risk Characterization – Aquatic

Risk Characterization – Aquatic

Maximum Drift Deposition Table

Maximum Spray Drift Deposition % Drift at 1 m downwind

Risk Characterization – Aquatic

Risk Characterization – Aquatic

Risk Characterization – Aquatic

Risk Mitigation Measures - Examples

• Reduce number of applications per season

Some Areas Requiring Further

Drinking Water Estimates for Human

Toxic Substances Management Policy

Environmental Risk Assessment – Case

Abiotic Transformation: Parent

• Soil: half-life: 2.8–18 d

Field Dissipation – Parent

• Terrestrial field dissipation

Data submitted for transformation

Overall Conclusion – Persistence

• Adsorption-desorption – parent was not stable in

• Overall conclusions considering log Kow, pKa, and

Screening Level Risk Assessment –

• LOC was not exceeded for earthworm, honeybee, rove beetle,

Refined Risk Assessment –

Screening Risk Assessment –

Refined Risk Assessment –

Screening Risk Assessment –

Vascular Seedling EUP 30.9 Yes Buffer zones

Screening Level Risk Assessment –

Refined Risk Assessment –

Screening Level Assessment –

Refined Risk Assessment –

Screening Level Risk Assessment –

Refined Risk Assessment –

Overall Environmental Mitigation

• Studies often not submitted

• USC DACO Tables

Reference Documents (cont’d)

• Pesticide Incident Reporting

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