data collection and utilization for standard setting (both

Data Collection and utilization

for Standard setting

(both national and international) case study MRL

Panpilad Saikaew

National Bureau of Agricultural Commodity and Food Standrds

National Training Workshop on Strengthening Food Standard Setting and Participation in Codex activities in Cambodia

19 – 21 February 2014

Outline

Principle of national MRL Establishment

Establishment of MRL

Use of data in MRL establishment

How to generate the data used in MRL

- supervised residue trial data

- consumption data

Benefit of the data collection

Principle of national MRL Establishment Set MRL for all commodities which the pesticide is allowed to be used

Reference is made to Codex/ASEAN MRLs, where available In case of no Codex/ASEAN MRL, the following data are used : – Supervised residue trial data & Monitoring data – Other national MRLs e.g. EU, USA, Australia, Japan – Other Codex/ASEAN/National MRLs on related commodities – Other related and available data e.g. monitoring data

WHO Panel FAO Panel

Toxicological + others

ADI/ARfD

Use Patterns = GAP

Supervised Residue Trial

MRL - Recommendation

Exposure assessment

Proposed Draft MRL

JMPR

Establishment of Codex MRLs

Codex/JMPR

ACFS

ADI/ARfD

Approved label = GAP

Data i.e. Codex MRLs Supervised Trial, other

national MRLs


Exposure assessment

MRL Adoption

Agricultural Std

Committee

Technical Committee

Establishment of the Thai MRLs

Use of Data in MRL Establishment

Process of MRLs Establishment

• Set pesticide priority for MRLs establishment

• Data collecting & analysis

• Propose draft MRLs

• Risk assessment based on proposed MRLs

• Adopt MRLs

Use of Data in MRL Establishment

Data needed for setting MRLs

• Codex MRLs/ ASEAN MRLs

•Supervised residue trials data/ monitoring data

• Toxicological data

• Consumption data

• Others e.g. other national MRLs, processing factor

How to generate and use

those data for setting MRLs

Supervised residue trial data

Prioritizing regarding with the JMPR evaluation program

Conducting the SRT followed FAO Guidelines for

conducting Pesticide Residue Trials to Provide Data for the

Registration of Pesticides and the Establishment of

Maximum Residue Limits

Analyzing the data


These SRT data is uesd for

o setting national MRLs

o submitting data to EWG-MRLs for setting

ASEAN MRLs

o submitting data to JMPR by followed FAO

Manual on the Submission and Evaluation of

Pesticide Residues Data

Codex/JMPR

ACFS

ADI/ARfD

Approved label = GAP

Data i.e. Codex MRLs Supervised Trial, other

national MRLs


Exposure assessment

MRL Adoption

Agricultural Std

Committee

Technical Committee

Establishment of the Thai MRLs

Risk Assessment of the Proposed MRLs

• All proposed MRLs must ensure safety to consumer by apply appropriate risk assessment using Codex technique

• Intake calculation is conducted, assuming that all food consumed contain residue at MRL (worst case)

• Consumption data was used in the intake calculation

• Both chronic and acute intake were included in the calculation

• All MRLs/EMRLs have to pass the assessment that provide sufficient safety to consumer before they can be submitted for adoption as national MRLs

Dietary Exposure to a Hazard

Consumption of a Food containing the Hazard

x Hazard Level in the Food

Residue Intake Calculation

• Chronic intake calculation for each pesticide residue Compared with Acceptable Daily Intake (ADI)

• Acute intake calculation for each MRL of each pesticide residue Compared with Acute Reference Dose (ARfD)

Chronic Exposure Assessment

Chronic intake =

Food consumption x Concentration Body weight

Compare intake to ADI

= Risk characterization

Acute Exposure Assessment = intake from one food in one meal or day

Calculate “National Estimated Short-Term Intake (NESTI)

3 cases of intake calculation depended on food

commodity unit weight

Case 1 : food commodity unit weight ≤ 25 g

Case 2 : food commodity unit weight > 25 g

Case 3 : processed Commodity is bulked or blended;

including milk

Acute Exposure Assessment

Case 1 - food commodity unit weight ≤ 25 g

- also applies to meat, edible offal, eggs

NESTI = LP x HR

bw

LP = Large portion consumption (97.5th percentile of

eater)

HR= Highest residue found from supervised trial data


Case 2 : food commodity unit weight > 25 g

Case 2a unit weight edible portion (U) < LP

NESTI = (U x HR x V) + [(LP-U) x HR]

bw V = Variability factor ( JMPR use a default V = 3 )


Case 2b U ≥ LP

NESTI = LP x HR x V

bw


Case 3 Processed Commodity is bulked or blended; including milk

NESTI = LP x STMR-P bw STMR-P = supervised trials median residue in processed commodity

National consumption data

530 Food items

Published by ACFS

National Consumption Survey

Institute of Nutrition, Mahidol University

National Consumption Data of Thailand

Aims of the survey

• To obtain a comprehensive food

consumption database for exposure

assessment of food chemicals and others

• To be used as a key information in

establishing food and agricultural standards

• To be used as a key information in

establishing health promotion strategies

related to food and nutrition of the

population

National Food Consumption Survey

• 4-years project started in 2002, responding to

food safety purpose

Planning, Preparation & Pilot survey – 2002-2003

1st Survey – Dec 03-Mar 04

2nd Survey – Sep 04-Dec 04

Data analysis - Jan 05-Mar 06

Publishing of Food Consumption Data – Dec 06

Consumption patterns related to

• Population demographics

– Age, gender, socio-economic characteristics

• Season (selected food item such as fruits)

• Region

Scope/Method of the Study

• Study of individual consumer

• Semi- Quantitative Food frequency

• All 4 regions (N, NE, C & S) and Bangkok also

both urban and rural areas included

represent national consumption

• Large sample sizes (people) ~ 20,000

• As many food items as possible included

• Body weight also needed

Survey methods Target population 19,046 respondents randomly selected from representative provinces of each region Sampling technique Stratified 3-stage random sampling

Data collection sites

• North: Chiang Mai, Kampangphet, Pichit, Sukhothai

• Northeast: Nakhon Ratchasima, Khon Kaen, Srisaket, Kalasin

• South: Suratthani, Pang Nga, Songkhla, Satul

• Central: Ratchaburi, Cholburi, Lopburi, Angthong

• Bangkok

People in The Survey

Age Male Female Total % 0-3 1184 1179 2363 12.6 3-6 1106 1121 2227 11.9 6-9 1165 1170 2335 12.5 9-16 1224 1240 2464 13.1 16-19 1132 1154 2286 12.2 19-35 1229 1215 2444 13.0 35-65 1245 1321 2566 13.7 >65 1031 1030 2061 11.0 >3 8132 8251 16383 87.4

Total 9316 9430 18746 100

Food items for the survey

Age group 0-3 year 146 items from 9

food groups

7 Age groups > 3 year 384 items from

18 food groups

Food groups divided for national food consumption survey

1. Cereal and its products

2. Root and its products

3. Bean, seed and products

4. Vegetable

5. Fruit

6. Meat and its products

7. Marine aquatic animals

8. Egg

9. Milk and its products

10. Lipid (fat and oil)

11. Sugar

12. Herb and spice

13. Alcoholic/Liquor

14. Beverage

15. Snack

16. Dessert

17. Food supplement

18. water

530 Food items

Data collection tools • Questionnaires

– Household and individual questionnaire on

eating pattern

– Semi-quantitative food frequency

questionnaire (individual)

– 24-hour dietary recall

• Record form

– Body weight and height

Portion size measurement tools

Consumption Data Reporting

• 8 Age groups

• Baby & Young children (0-3 y) vs. General

population (>3 y)

• Male, Female & All sex

• Consumption per capita/day vs. Eater

only/eating day

• Average (mean) vs. High percentile (97.5 Perc.)

• Consumption data from survey reported as

“edible portion as consumed”

Consumption Data Reporting

Per Capita Mean

Eater only 97.5

Per Capita

• The consumption of a food item by

population calculated per person per day

• Reported as g food/person/day

• Normally used for chronic exposure

assessment (e.g. food additives,

contaminants, pesticides) and evaluate of

nutrient intake (under or over intake)

Eater Only • The consumption of a food item by eater of

that food in a single meal or day (WHO use

a single day for acute exposure assessment)

• Reported as g food/person(eater)/day or

g food/kg bw/day

• Normally used for acute exposure

assessment (e.g. some pesticides,

pathogens) and evaluate of consumption

pattern of a single meal or day

Consumption Data

• For chronic intake : mean per capita consumption (g/person/day)

• For acute intake : 97.5 percentile eater only consumption (g/person/day or g/kg bw/day) = Large Portion (LP)

• General population (> 3 year) and children (3-6 year)

• Submitted data to GEMs/Food database

New National Food Consumption Survey • 3-years project started in 2013, responding to food

safety purpose

Planning, Preparation & Pilot survey: Feb 13 – Feb 14

1st Survey: Mar 14-May 14

2nd Survey: July 14-Sep 14

3rd Survey: Nov 14- Feb 15

Data analysis: Mar 15-Oct 15

Scope/Method of the Study

• Same as the previous survey

• All 4 regions (N, NE, C & S) and Bangkok also

both urban and rural areas included

represent national consumption

• Target population: 8400 repondents

Data collection tools • Questionnaires (software)

– Household and individual questionnaire on

eating pattern

– Semi-quantitative food frequency questionnaire

(individual)

– 24-hour dietary recall

• Record form

– Body weight and height

Benefit for data collection

Reflect the real situation

• Own data used in the process of standard establishment

Ensure the consumer’s safety

• Risk assessment based on the own national

data

Facilitate the agricultural trade

• the MRLs for tropical agricultural commodities

data collection and utilization for standard setting (both

Documents