1. Pesticide Residues, MRLs, Dietary Risk and Trade Assessment at the APVMA
Dr Jason Lutze BAPHIQ
Pesticides Residues Manager Canberra Dec 2012

2. Today’s presentation Residues assessment – data and approach
MRL estimation
Dietary Exposure
FSANZ
MRL establishment
Trade

3. Legislative Background
Assessment Criteria are defined in the legislation (s.14)
Can only register a product if:
is not an undue hazard to people (handling products or residues)
Would not be likely to have an effect that is harmful to human beings
does not have an unintended harmful effect on plants, animals or the environment
does not unduly prejudice trade
is shown to be effective

4. APVMA Assessment Framework
Each element of the s.14 criteria translates into an assessment discipline to which are linked requirements and guidelines (MORAG)
The Residues assessment is linked to best practice internationally accepted principles, e.g. FAO, WHO, OECD
Pesticide residues group active in these committees
OECD guidelines utilised although not yet formally referenced in MORAG
Australian only elements e.g. trade assessment.

5. Residue assessment and MRL estimation

6. Elements of a Residues Risk Assessment
Define residue in food: residue definition
Assess methods of analysis
Set standards to be used as legal limits for monitoring; Maximum Residue Limits
Assess dietary exposure; chronic and short-term
Recommend withholding periods & label directions

7. Residue definition
Data requirement and evaluation consistent with OECD / FAO guidance
Aim is to keep analysis as simple as possible while effectively addressing risk
May establish separate definitions for plant and animal commodities
But only one for plant and one for animals (milk?)
May establish separate definitions for tolerance establishment (enforcement) and risk assessment

8. Analytical methods Consistent with OECD / JMPR guidance
Require validated methods for plant and animal commodities regardless of proposed use
Generally need to establish animal commodity MRLs
Do not establish regulatory methods
Guidance given in expression of residue definition if required
Residue monitoring programs performance based

9. Maximum Residue Limits – plant commodities - data
Requirements consistent with OECD guidance
8-12 major, less for minor crops
Emphasis on residue decline data
Codex commodity definitions
Can utilise international data if GAP similar
For minor uses international data can form a substantive proportion of the data
Processing data
Animal feed commodity and failed crop data required
Extrapolation

10. Maximum Residue Limits – plant commodities - evaluation
MRL determination/recommendation processes consistent with JMPR
JMPR steps utilised
1, 2, 3, 5, 7
May be reviewed in future (minor use)
OECD calculator
Used to inform decisions rather than as the determinant of the MRL
Evaluators expert knowledge of dataset, commodity and use pattern still needed

11. Maximum Residue Limits – animal commodities – why?
Legal limit
(but generally not for compliance monitoring for pesticide use)
Dietary exposure assessment
International trade
Routinely established for any new pesticide used in food producing situations

12. Maximum Residue Limits – animal commodities – data requirements
Consistent with OECD
Metabolism & feeding/transfer
OECD feeding tables
Extensive livestock production
‘mixed’ farming
Use of by-products (tomato pomace)
Trade considerations may impact on feeding study design
Depuration phases preferred in all cases

13. Maximum Residue Limits – animal commodities – establishment
Consistent with OECD/JMPR
Correlation of the percentage of the feed item in the total diet of the animal with the expected residue (HR/STMR)
Maximum Reasonably Balanced Diet not utilised (extensive production).
Grazing withholding period and MRL established
Consideration also given to management advice for trade risk (later)

14. Dietary Exposure Assessment

15. Dietary Exposure Assessment
Health standards established by AUS Dep of Health
Food Consumption data from Food Standards Australia New Zealand (FSANZ).
Procedures consistent with WHO/JMPR and are agreed with FSANZ
Exposure via food consumption only (not aggregate)
Generally single active (not cumulative)

16. Dietary Exposure Assessment
Chronic exposure
National Estimated Dietary Intake
Acute exposure
National Estimated Short Term Intake
Deterministic 97.5th consumers

17. MRL Establishment Australia has 2 MRL Standards
APVMA MRL Standard: referenced for control of use
FSANZ MRL Standard (Food code / std 1.4.2): referenced for sale of food
Legislative reforms came into effect in March 2011
Allow APVMA to directly vary FSANZ MRL standard
New legislative arrangements reduced lag from 9-18 months to <16 weeks
10-14 weeks so far
Lag associated with WTO notification requirements

18. Trade

19. Trade
Can only register a product or approve a use if it does not unduly prejudice trade
Australian legislation unique for requirement to consider trade

20. Trade Consultations APVMA consults with relevant parties including:
Commonwealth / State / territory government authorities
Grower / producer organisations
Consumers
Consultation through publication of residues and trade information in either:
Public release summary (PRS) – (new product/active)
Trade advice notice (TAN) – (extension of use of existing product)

21. Applications Requiring Trade Information
Trade information required if residues above LOQ in the following commodities:
Cattle, cattle dairy products, pigs, sheep, goats, poultry and eggs.
Cereal grains, citrus fruit, grapes and wine (including dried grapes), oilseeds – canola seed and cottonseed (including derived oils and meals), pome fruit, pulses – lupins, field peas, chickpeas, faba beans, navy beans, mung beans, stone fruit, sugar, oaten hay.

22. Applications Requiring Trade Information (2)
Trade information also required if:
A stockfood derived from treated materials has residues above the LOQ and produces residues in animal tissues when fed to an animal in the listed group.
Treated pastures and crops, which can be fed to or grazed by stock, have quantifiable residues and produce residues in animal tissues when fed to an animal in the listed group

23. Factors Considered by the APVMA
Whether a potential trade risk exists (eg due to inconsistencies between Australian and trading partner’s MRLs).
The applicant’s proposals to minimise an identified trade risk.
The capacity of affected industries to manage any such risk.

24. Strategies to manage trade risks
Establishment of export intervals.
Establishment of bilateral import tolerances.
Alternative industry specific management strategies.

25. Types of export intervals
Export slaughter interval.
Export harvest interval.
Export animal feed interval.
Export grazing interval (relating to continuous grazing).
(All advisory statements – not mandatory)

26. Export slaughter interval
The minimum period of time that should elapse between:
The last treatment of an animal with a veterinary chemical product and the slaughter of that animal for export. or
The removal of grazing livestock to clean pasture or feed, and slaughter, where the livestock have been grazing the crop / pasture prior to expiry of the export animal feed interval.

27. Export slaughter interval
Central list for veterinary chemicals
Less ESIs established for agricultural chemicals
On labels or permits
eg. Plague locust control

28. Export harvest interval
The minimum period of time that should elapse between the last application of an agricultural chemical product (pesticide) to a crop, and harvesting of the commodity for export.
Generally industry managed

29. Export harvest interval
Wine grapes – “the dog book”
Contains use recommendations for export production generally
Citrus – Guide to achieving export market MRLs
Advice specific for target market

30. How are Export Intervals Determined?
Similar process to withholding periods
Market standard to be addressed needs to be defined
Consultation undertaken to establish significant markets for animal commodities
Value of markets to industry
Strategic importance

31. Markets for consideration in export slaughter interval determination for cattle, pigs and sheep
Codex 
China EU
Japan
Republic of Korea
Russia
Saudi Arabia
Singapore
Taiwan
UAE
USA

32. How is observance with export intervals determined?
Industry based systems
For livestock – LPA QA/Food safety scheme
Use of vendor declarations required under rules
Buyers of livestock almost exclusively require completed declarations

33. Thank you – Questions?