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2010 Maximum Residue Level (MRL) Workshop – Global ... Residue Decline Curves.pdf · 2010 Maximum...

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  • 2010 Maximum Residue Level (MRL) Workshop Global Regulations

    Residue Decline Curves Related to MRLsSan Francisco, CA

    June 2-3, 2010

    Phil Brindle, PhD Global MRLs & Import Tolerances

    BASF Aricultural Solutions, Research Triangle Park,NC 27709, USA

    Email: [email protected]: +1 919 547 2654

  • 2

    MRLs, Residue Data and Label Directions

    Declines Curves

    Secondary Residue Standards vs. MRLs

    Value of Decline Curve Data

    Structure of Presentation

  • 3

    Regulatory Definition of MRL

    Maximum Residue Level (MRL) legally allowed in/on food, or animal feedstuff, after use of crop protection chemical according to Good Agricultural Practice (GAP)

  • 4

    How are MRLs set?

    Calculated on basis of residue data generated according to a specific use pattern (worst-case conditions)

    Max application rate

    Timing of application

    Max number of applications

    Min spray interval between applications

    Shortest Pre-Harvest Interval (PHI)

    Residue data MRL setting

  • 5

    Residue Data set for MRL setting

    0.3112 x 0.24L080004 Sevilla, Spain

    0.3012 x 0.24L080003 Teramo, Italy

    0.7812 x 0.24L080002 Thessaloniki, Greece

    0.2512 x 0.24L080001 Gard, France

    0.6612 x 0.24L070381Sevilla, Spain

    0.2212 x 0.24L070380Milano, Italy

    0.4912 x 0.24L070379Heasaloniki, Greece

    0.6212 x 0.24L070378Gard, France

    Residues(mg/kg)PHI (days)kg as/haTrial #Location

    Tomato-Insecticide X

  • 6

    MRL is based on residue values which reflect specific GAP (incl. PHI)different PHI different residues different MRL!

    GAP, PHI, MRL & Product Label relationship

  • 7

    Typical Residue Decline Curve

    0

    0.5

    1

    1.5

    2

    2.5

    3

    3.5

    0 5 10 15 20 25 30 35 40

    What is a Residue Decline Curve?

    Determines residues at a range of PHIs according to a particular GAP

    PHI

    mg/

    kg

  • 8

    Lettuce Decline Curve

    PHI

    01234

    56789

    0 5 10 15 20 25

    mg/kg

    Lettuce DC of Fungicide

  • 9

    PHI (days)

    00.05

    0.10.15

    0.2

    0.250.3

    0.350.4

    0.45

    0 5 10 15 20 25 30

    mg/kgmg/kgMetabolite

    Parent

    Apple Decline Curve with Parent and Metabolite

    Apple DC of Fungicide

  • 10

    PHI (days)

    00.05

    0.10.15

    0.2

    0.250.3

    0.350.4

    0.45

    0 5 10 15 20 25 30

    mg/kgmg/kgmg/kg

    Residue definition includes parent + metabolite

    Apple DC of Fungicide

    Apple Decline Curve with Parent and Metabolite

    ParentMetabolite

    Total

  • 11

    Include 3 to 5 sampling intervals in addition to the target PHI

    Include 0 day sampling (can be target PHI)

    Set sampling intervals at shorter and longer time points relative to the target PHI

    For multiple applications, set a sampling point immediately prior tothe final application determinescontribution of earlier applications

    DCs are generally run alongsideAt Harvest trials, i.e. commercial PHItarget interval for label

    Design of Residue Decline Curve

  • 12

    Residue Decline Curves for Bell Pepper

  • 13

    MRLs are trading standards; they have been established by Regulators using strict, scientific-based, dietary intake evaluations

    Secondary standards are private, arbitrary standards establishedby Retailers and Food Processors

    MRLs vs. Secondary Residue Standards

    Pesticide listsStandards less than MRLMaximum number pesticidesNo detectable residues

  • 14

    2ndary StdCompliance

    Pressure

    RetailersFood Processors

    Consumers6.8 billion

    FARMERSFoods/Feeds

    Domestic ProductionExports/Imports

    DISEASESINSECTSWEEDS

    CPI

    National/RegionalRegulators

    Registered CPCs

    Regulatory MRLs

    Regulatory Import

    Tolerances

    External Pressure

    External

    Pressure

    2ndary StdProliferation

    Pesticide scare -dont eat apples or pears!

    Emotive Messages

    Pressure Pressure Pressure

    Secondary Standards: pressure for growers

  • 15

    max 1/3 MRLmax 100% ARfD (sum)

    max 70% MRLmax 70% ARfD

    max 70% MRLmax 50 % MRL

    (for own brands )

    max. 3-5 activesmax 70% MRL (sum)max 70% ARfD (sum)

    max. 5 activesmax 80% MRL (sum)

    max 80% ARfD

    max. 3-5 activesmax 80% MRL (sum)max 80% ARfD (sum)

    Secondary Residue Standards, which undercut and undermine regulatory MRLs, are becoming commonplace around the world because the major food retailers are sourcing and expanding globally

    Secondary Standards

  • 16

    Value of DC from Regulatory perspective

    Provides information on rate of disappearance of parent residue

    Provides information on rate of increase/decrease of metabolites

    Aids decision-making for inclusion/exclusion of metabolites inresidue definition for both dietary assessment and MRL setting

    Predicts residues at an alternative PHI in case dietary risk concerns are encountered with target PHI

    Determines time to reach maximumresidue level for systemic compound

    Useful data for assessing agricultural worker re-entry periods

  • 17

    Value of DC from Grower/Exporter perspective

    Provides information on total residues at different harvest intervals compared to worst-case minimum PHI on label, which was used for MRL setting

    Shows importance of adhering to label instructions with respect to PHI in order to stay within domestic MRL

    Information can be used toestimate a later harvest intervalin order to comply with a lowerforeign market MRL, or acustomers Secondary ResidueStandard

  • 18

    Residue Decline Curves for Bell Pepper

    Label PHIMRL = 1 mg/kg

    Foreign MarketMRL = 0.4 mg/kg

  • 19

    Residue DC data are required for registration purposes by Regulatory Authorities

    DC data are helpful for estimating residues at range of PHI intervals

    DC data are collected for harvested commodities at the farm gate; residues decline during transit/shelf-life period

    Caution must be exercised in use of DC datasince residue data tend to show lots of variability!

    Analytical testing is always bestto confirm residue level

    A few concluding remarks

  • 20

    ..and please support Globally Harmonized MRLs, they make a world of difference!

    THANK YOU FOR YOUR ATTENTION

  • 21

    BACK-UP

  • 22

    Strawberry Decline Curve

    PHI

    00.10.20.30.4

    0.50.60.70.80.9

    0 5 10 15 20 25 30

    mg/kg

    Strawberry-fungicide A

  • 23

    Apple Decline Curve more stable compound

    PHI

    0

    0.5

    1

    1.5

    2

    2.5

    3

    0 5 10 15 20 25 30 35 40

    mg/kg

    Apple-fungicide B

  • 24

  • 25

    (vi) Residue decline studies. (A) Residue decline studies are required.Such data will be needed for uses where the pesticide is appliedwhen the edible portion of the crop has formed or it is clear that quantifiableresidues may occur on the food or feed commodities at, or close to,the earliest harvest time. The primary purpose of these studies is to determineif residues are higher at longer PHIs than requested and the approximatehalf-life of the residues. In addition, such studies are frequently ofgreat value for determining an appropriate tolerance when a use patternis changed. The number of decline studies needed is one for crops requiring5 to 12 total trials and two for crops requiring 16 to 20 total trials.These studies are included in the 5 to 12 or 16 to 20 trials (i.e. not inaddition to these numbers of trials). Decline studies will not be requiredfor crops needing three or fewer total trials.(B) The design of the decline studies should include 3 to 5 samplingtimes in addition to the requested PHI. The sampling times should all fallwithin the crop stage when harvesting could reasonably be expected tooccur. The time points should be approximately equally spaced and, wherepossible, represent both shorter and longer PHIs than that requested. Ofcourse, shorter PHIs cannot be examined in the case of a use with a zerodayPHI. In addition, for an at-plant/preplant use, the PHI is usually predeterminedby the length of the growing season of the crop. Therefore,for such uses that result in quantifiable residues, petitioners should attemptto stretch the harvest period by sampling immature fruit, tubers, etc. ifnecessary.

  • 26

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