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

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

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

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.

Residue assessment and MRL estimation

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

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

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

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

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

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

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

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)

Dietary Exposure Assessment

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)

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

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

Trade

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

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)

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.

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

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.

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

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)

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.

Export slaughter interval Central list for veterinary chemicals http://www.apvma.gov.au/residues/ESI.shtml Less ESIs established for agricultural chemicals On labels or permits eg. Plague locust control

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

Export harvest interval Wine grapes – “the dog book” http://awri.com.au/industry%5Fsupport/viticulture/agrochemicals/agrochemical%5Fbooklet/ Contains use recommendations for export production generally Citrus – Guide to achieving export market MRLs http://www.australiancitrusgrowers.com/aspdev/marketing/export/mrl_listing.asp? Advice specific for target market

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

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

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

Thank you – Questions?