Professional Documents
Culture Documents
Pesticide Residues
based on SPRT data
Sri Noegrohati
Fac of Pharmacy
Gadjah Mada University
Estimation of Pesticide
MRLs
Plant
metabolism
identity
of the
residue
Farm animal
metabolism
RISK ASSESSMENT
Are the toxicology and dietary
intake of residues compatible?
Sri Noegrohati, G
Hazard
Sri Noegrohati, G
HAZARD
CHARACTERIZATION
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Dose-response
extrapolation
Sri Noegrohati, G
Toxicological endpoint
Effect, toxic and
Lethality
acute: ED50, TD50, LD50
Chronic: NOAEL
Sri Noegrohati, G
Standard method
OECD guideline 407 (14 to 28 days)
OECD guideline 408 (90 days) for subchronic studies
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Environmental Safety
evaluation
Sri Noegrohati, G
Scope
Organisms
Toxicity
End point
Selenastrum
capricornutum
(microalgae).
Lepidium sativum,
Form:
Untreated seeds,
stored at 4C
Inhibition of seed
germination EC50
and %root elongation
IC50
Daphnia magna, a
primary consumer
crustacean
Screening, Acute
toxicity (24h to 48h)
of dissolved
chemicals at early
life stage
Artemia francisana,
a thrive euryhaline
marine species,
Form: Cysts
Screening, Acute
toxicity (24h) of
dissolved
chemicals at the
early life stage
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CONSUMPTION
Sri Noegrohati, G
Far Eastern
Consumption
g/person/day
279.30
114.80
19.20
11.00
43.00
14.20
11.20
9.70
18.20
12.50
12
Intake g/person/day
Food Intake
WHOGEMS
BPS
(2005)
TOTAL CEREALS
617.0
282.7
119.7
40.3
TOTAL PULSES
41.9
17.5
58.6
42.6
14.9
14.9
12.2
TOTAL STIMULANTS
2.9
TOTAL SPICES
2.3
TOTAL VEGETABLES
270.9
106.0
47.4
40.8
TOTAL EGGS
22.1
17.5
148.4
67.9
66.0
7.1
TOTAL FRUITS
TOTAL MILK AND MILK
PRODUCTS
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G
TOTAL MEAT
AND OFFALS
77.6
13
14.9
Distribution of exposure
Compare to
tox endpoint
Number of People
Number of People
Distribution of residues
99.9th percentile
Distribution of consumption
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INPUTS
Acceptable Daily Intake (ADI)
estimate of the amount of a substance in food
and/or drinking-water, normally expressed on a
body weight basis, that can be ingested daily over
a long-term (month, year, lifetime), without
appreciable health risk to the consumer on the
basis of all the known facts at the time of the
evaluation.
ADI are expressed in mg substance/kg body
weight/day.
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INPUTS
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Calculation of Chronic
Intake
TMDI = (MRLi Fi)
IEDI = (STMR-Pi Fi)
Where:
MRLi
STMRi (or
STMR-Pi)
Fi
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Calculation of Acute
Intake
IESTI =
LP * HR
bw
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Risk Evaluation
Example: SPRT of Deltamethrin in Indonesia
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Preparing a Data
Submission
Structure
Directory
1. Background information
2. Metabolism and environmental fate
3. Methods of residue analysis and data on freezer
storage stability
4. Use pattern
5. Residues resulting from supervised trials
6. Fate of residues in storage and processing
7. Residues in animal commodities
8. Residues in food in commerce or at consumption
9. National maximum residue limits and residue
definitions
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[LOGO]
TITLE:
[COMPOUND].
[NATIONAL GOVERNMENT]
SUBMISSION FOR JMPR 2005.
PURPOSE:
REPORT NUMBER:
NUMBER OF PAGES:
DATE OF ISSUE:
[xxxxx].
AUTHORS:
Background information:
explain the reasons
for the data
submission and
briefly list the
information included
in the report
persons]
ADDRESS:
[Full address
]
AUTHORISATION:
ADDRESS:
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Analytical methods
Summary information for each method is provided.
Method identification number and reference:
Substrates: [e.g. plant material, vegetable oils, wine]
Analytes: [parent compound, metabolite 1, etc]
LOQ: [0.05 mg/kg]
Recoveries: [e.g. 78-110% for plant material spiked at 0.05 to 2 mg/kg, n=12]
Method description: [Very brief summary, for example: Homogenized sampl es were
extracted with aqueous methanol. The extract was cleaned-up on a cation
exchange cartridge. HPLC (single-column or two-column-switching systems) with
UV detection (max 270 nm) was used for the final measurement.]
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Use pattern
Formulation Method
WP 900
foliar
Cherries SC 400
foliar
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Timing
Rate kg ai/ha
Spray conc
ka ai/hl
from bud
opening
from petal
fall
0.90
0.090
28
0.040
28
25
No PHI,
days
Crop:
Study report identification number:
Analytical method ident number:
Procedural recoveries:
Trial design:
Plot size:
Sprayer:
Sprayer calibration:
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Application
Form
kg ai/hakg ai/hl
PHI
water,
l/ha
Residues
28
Ref
Residues in food in
commerce or at
consumption
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