Risk Assessment of Pesticides Residue by JMPR - To set ADI and ARfD-

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1 The FAO Regional Training Course: Strengthening Capacity of Data Collection and Generation for Food Safety Risk Analysis Support to Capacity Building and Implementation of International Safety Standards in ASEAN Countries (GCP/RAS/280/JPN) Tokyo, Japan, June 2013 Risk Assessment of Pesticides Residue by JMPR - To set ADI and ARfD- Midori Yoshida National Institute of Health Sciences

2 Contents: 1. Purpose of the evaluation by JMPR 2. Assessment process in JMPR a. Quality of toxicological data b. Assessors c. NOAEL/LOAEL d. Kinetics/MOA 3. ADI setting 4. ARfD setting

3 Today s key words : Dr. Keyword ADI ARfD Data Quality (GLP, Test guideline)

4 1. Purpose of the toxicology evaluation by JMPR

5 To set Purpose 1.Acceptable Daily Intake (ADI) : The amount of pesticide to which human can be exposed daily for a lifetime without injury 2.Acute Reference Dose (ARfD) : The amount of pesticide that can be ingested in a period 24 hours or less without injury

6 2. Assessment process in JMPR

7 Toxicology data Assessors (Expert & member) Acute toxicity Repeated toxicity TK, MOA Reproductive Genotoxicity Carcinogenicity profile profile profile profile profile profile Discussion=Comments Setting NOAEL/LOAEL in each toxicity study Mode of action/special studies/ Human data Test guidelines Principles of /Accordance with GLP Monograph /Summary Chronic effects Acute effects ADI ARfD Outline of toxicological evaluation process in JMPR

8 a. Quality of toxicological data

9 Toxicology data Assessors (Expert & member) Acute toxicity Repeated toxicity TK, MOA Reproductive Genotoxicity Carcinogenicity profile profile profile profile profile profile Discussion=Comments Setting NOAEL/LOAEL in each toxicity study Mode of action/special studies/ Human data Test guidelines Principles of /Accordance with GLP Monograph /Summary Chronic effects Acute effects ADI ARfD Outline of toxicological evaluation process in JMPR

10 What are qualified toxicological data? Accordance with recognized test guidelines (OECD, EPA, EFSA, APVMA, HealthCanada, MAFF) Conducted to the principles of GLP (Good Laboratory Practice)

11 Why is quality necessary in submitted toxicological data? Robusty Transparency Consistency High impact factors are not needed Quality

12 b. Assessors

13 Toxicology data Assessors (Member & temporary adviser) Acute toxicity Repeated toxicity profile Reproductive Genotoxicity Carcinogenicity profile profile profile profile Discussion=Comments Setting NOAEL/LOAEL in each toxicity study Mode of action/special studies/ Human data Test guidelines Principles of /Accordance with GLP Monograph /Summary Chronic effects Acute effects ADI ARfD Outline of toxicological evaluation process in JMPR

14 JMPR Roster of Toxicological Experts Scientific experts Roles of roster Members Reviewing monograph Leading evaluation process Temporary Advisers Making draft monograph

15 Toxicology data Evaluators (Expert & member) Acute toxicity Repeated toxicity Reproductive Genotoxicity c. NOAEL/LOAEL Carcinogenicity TK, MOA profile profile profile profile profile profile Discussion=Comments Setting NOAEL/LOAEL in each toxicity study Mode of action/special studies/ Human data Test guidelines Principles of /Accordance with GLP Monograph /Summary Chronic effects Acute effects ADI ARfD Outline of toxicological evaluation process in JMPR

16 Data required in toxicological evaluation Toxicological studies Acute toxicity (rats, mice) Short-term toxicity (rats, mice, dogs) Long-term toxicity/carcinogenicity (rats, mice) Genotoxicity (in vitro, in vivo) Reproductive toxicity (rats, rabbits) Special study=neurotoxicy/immuotoxicity/mechanistic(mode of action, MOA) study Biochemical aspects = Kinetics/ADME Observation in humans

17 How to set NOAEL/LOAEL No Observed Adverse Effect Level (mg/kg bw per day) Lowest Observed Adverse Effect Level (mg/kg bw per day) Set NOAEL/LOAEL in each study Rosters determine NOAEL based on endpoints at lowest dose detected toxicity/adverse effect Dose tested /adverse effect LOAEL 100 mg/kg bw 20 mg/kg bw Hepatocellular necrosis Anemia Body weight decrease Body weight decrease Endpoint to set NOAEL NOAEL 5 mg/kg bw

18 d. Kinetics/MOA

19 What is くすりの useful information 毒 性 を 理 解 for するためにまず toxicological 理 evaluation? 解 すべきこと! What is ADME? Absorption Distribution Metabolism Excretion Chemicals Absorption Metabolism Metabolism Distribution Distribution Absorption Excretion Excretion

20 Concentration in blood くすりの 毒 性 を 理 解 するためにまず 理 解 すべきこと! What is useful information for toxicological evaluation? Kinetics data =Biochemical aspects 100 C max Toxicokinetics (TK) 50 AUC T max T 1/2 Time after treatment Toxicokinetics (TK) Better understanding toxicological profiles

21 Acute toxicity Reproductive What is useful information for toxicological evaluation? Toxicology data Repeated toxicity Genotoxicity Assessors (Expert & member) TK, MOA Carcinogenicity profile profile profile profile profile profile Discussion=Comments Setting NOAEL/LOAEL in each toxicity study Mode of action/special studies/ Human data Chronic effects Acute effects Test guidelines Principles of /Accordance with GLP Monograph /Summary ADI ARfD Outline of toxicological evaluation process in JMPR

22 Mechanism (Mode) of action Are the animal data sufficient for MOAs? Yes Is the animal MOA plausible in humans? Are animal kinetics/ dynamics similar to humans? Yes Yes No Species difference Relevant or Unknown Human Relevance Not Relevant in Humans MOA is Helpful information on relevance to human risk

23 3/4. ADI/ARfD setting

24 Toxicology data Assessors (Expert & member) Acute toxicity Repeated toxicity TK, MOA Reproductive Genotoxicity Carcinogenicity profile profile profile profile profile profile Discussion=Comments Setting NOAEL/LOAEL in each toxicity study Mode of action/special studies/ Human data Test guidelines Principles of /Accordance with GLP Monograph /Summary Chronic effects Acute effects ADI ARfD Outline of toxicological evaluation process in JMPR

25 3. ADI setting Acceptable daily intake (ADI) : Setting on the basis of the lowest relevant NOAEL in the most sensitive species. POD UF Lowest NOAEL Default = 100 Usually chronic effects in all toxicity studies POD, point of departure; UF, uncertainty factor

26 4. ARfD setting Acute reference dose (ARfD) : POD UFs Lowest NOAEL Default = 100 ARfD>=ADI Cut-off value All indications after single exposure Clear explanation

27 Toxicology data Assessors (Expert & member) Acute toxicity Repeated toxicity TK, MOA Reproductive Genotoxicity Carcinogenicity profile profile profile profile profile profile Discussion=Comments Setting NOAEL/LOAEL in each toxicity study Mode of action/special studies/ Human data Test guidelines Principles of /Accordance with GLP Monograph /Summary Chronic effects Acute effects ADI ARfD Outline of toxicological evaluation process in JMPR

28 Reference IPCS: Environmental Health Criteria 240 Principles and Methods for the Risk Assessment of Chemicals in Food Thank your attention for my presentation National Institute of Health Sciences since1874 NIHS

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