Section 6 Residues Anne Theobald Scientific officer, PRES Unit - PowerPoint PPT Presentation

TG IUCLID PESTICIDES meeting 21-22 April 2020 Section 6 Residues Anne Theobald Scientific officer, PRES Unit Jane Richardson Team leader, DATA Unit

Summary Introduction Different GAP tables Pilot project in MRL applications Next steps under IUCLID Discussion 2

Objective As discussed at the weekly technical group meeting; the objective for this session is to agree adaptations to OHTs which can be proposed to the OECD expert group by the end of April for inclusion in the October release of IUCLID (i.e. straight forward and non-controversial amendments). Where the sub-group agrees a more thorough review of an OHT is required (i.e. deeper review and further discussion needed), it is sufficient to identify these documents which a can be analysed at a later phase in the project and worked on in small group over the year and may be submitted to the OECD expert group for the next revision in April 2021. 3

OHT 85 Series  OHT 85-2 Metabolism in Livestock  OHT 85-3 Metabolism in Crops  OHT 85-4 Residues in Livestock  OHT 85-5 Residues in crops (field trials) and in rotational crops (limited field studies)  OHT 85-8 Nature of Residues in Processed Commodities  OHT 85-9 Magnitude of Residues in Processed Commodities  OHT 85-10 Stability 4

 OHT 85-2 Metabolism in Livestock [1/2] BL: 1786  CA, Section 6.2 > Capps (2002) Livestock metabolism studies: Is there a place for reporting information on the untreated controls? CA, Section 6.2 > Capps (2002): Sometimes livestock metabolism study reports contain only the dosing part or only the analytical part of the study. Could the data input sheet be designed more according to this by, for example, having alternative input sheets if not both are included?  Other comments  Used for classification/SDS: can be skipped (line 7 and 8)  Study period: in the help text it could be defined, e.g. start date is the signature of the contract with the lab or other and end date final agreement of the report. It should be also specified what is the in-live period and what is the period when measurements of specimen were carried out. In addition to the free text field a date drop down for start and end date could be included. (line 9)  “Radiolabel no” (line 46) and “dietary remime no” (line 66). Field name not clear. - Helptext to be improved 5

 OHT 85-2 Metabolism in Livestock [2/2]  It is often of interest where the label was introduced, e.g. phenyl label therefore the information should be introduced also here as a remark field and not in the section “radiolabel Remark” (line 46)  “SMILES notification”: it would be more appropriate to make reference to INCHIKEY (line 47)  Species (line 56)  Add fish in the dropdown list and in other relevant places (e.g. line 172 matrix)  In case, “other” is selected a box with free text should allow to include justification of the choice of the test animal  Entry 60 “health status/condition of animals” and 61.”health status” seem to dublicate information  “feed consumption” It is this the average feed consumption or should ranges be reported (line 68)- Helptext to be improved  “treatment level” (line 78) and “dosage level” (line 81): clear indicate where to insert e.g. mg/kg feed and where mg/kg bw Helptext to be improved  “route of administration”: all except oral are not relevant - 6  Metapath aspect for fish, New document for fish

 OHT 85-3 Metabolism in Crops [1/2]  “radiolabel no” (line 45): In case of parent structures constituted of several cycles and only one radiolabel is used, a robust justification should be provided that the fate of the molecule in plants is completely tracked without additional radiolabels on the structure. ฀ Additional field needed (also in animal/processing metabolism study)  “Type of rotational crop” (line 55). The picklist should refer to the representative rotational crops groups as agreed in the OECD Test Guideline 502.  “other details of test crops” (line 66):  The pre-harvest intervals for primary crops should also be added.  RAC: this should be a picklist like in OHT 85-9 7

 OHT 85-3 Metabolism in Crops [2/2]  “method of application” (line 88): A picklist for the different modes of application should be proposed and agreed with the purpose to harmonise the GAPs.  “Rate(s) of application” (line 89): picklist for the units of expression of the rates of application should be proposed and agreed.  “Other details on characterisation and identification of residues” (line 183): the analytical methods to characterize and identify the radioactive residues should also be reported with the validation datapackage  Minor (line 128): not livestock metabolism study but plant metabolism study 8

 OHT 85-4 Residues in Livestock  New BG: add fish to species list (line 45) – see metabolism  Reference to QSAR not relevant  Use for SDS and classification not relevant  Type of study (line 31): better explanation of difference of livestock feeding and direct animal treatment. Latter might not be acceptable in this context  Remarks regarding radiolabel and other elements of the metabolism not relevant (line 42 and 43 and others)  treatment type (line 49): inhalation and dermal not relevant 9

 OHT 85-8 Nature of Residues in Processed Commodities  Minor: reference to not relevant entries:  QSAR (line 3,4, 11, 14, 17, 20, 32, 36)  Testing proposal on vertebrate animals (line 14, 29)  Magnitudes of fortification levels  analytical method should be adapted with the type of study (i.e. method for quantitation of total recovered radioactivity; quantitative accountability of the total radioactivity). As are currently described the parameters for the analytical method are more for the magnitude of residues measurements (i.e. LOD) not for the investigation of the nature of residues (line 48) 10

OHT 85-9 Magnitude of Residues in Processed Commodities [1/2]  BL 1786:  Residues in RAC prior to processing and Residues in processed fractions: It is rather heavy to insert all the details separately in the sheets. There could be more free text slots. Check whether use of the copy feature could facilitate this work (line 55)  Storage stability factor (line 65, 67, 89, 109 and 111)  not very clear. What is this? This is part of the Bulk RAC sub-sample sample no.  The MoR in processed commodities should be investigated in the timeline in which the stability of residues in RAC was demonstrated. This field is rather confusing and is not an add value. Why is there by default aspirated grain fraction sheet? (IM) 11

OHT 85-9 Magnitude of Residues in Processed Commodities [2/2]  Specify the aspirated grain fraction to which the residue data summarised in the nested repeatable block 'Analyte measured' refer (line 76)  Minor: reference to not relevant entries:  QSAR (line 4, 20)  Testing proposal on vertebrate animals (line 40,41) 12

 OHT 85-10 Stability  BL 1881: The different options (fortification, incurred from residue trial or metabolism study) need to be addressed  BL 1785: Table format for results is suggested  “It is difficult to understand the residue level reporting slot. Reporting single values is not very practical, especially if not even parallel samples can be reported in the given form. A table format could be more suitable.”  Further options for reporting of results e.g. % of initial, % of nominal (after recovery correction) and the respective mean values  Predefined tables & Executive summary should be included in the IUCLID implementation  appropriate information on test items?!  an update of the pick list for commodities (see lines 44 and 55; proposal: consideration of EU crop list; Annex I of 396/2005).  an assignment of crops to commodity groups (see OECD 506) 13  Conclusion: significant efforts for suitable use (ECPA) ?!

 Recurring issues  Harmonization of crops (across all documents) in the OHT,  Inclusion of crop categories (instead of crop groups): see OECD 501  OHT 9 pick list of RAC  Reference to QSAR not relevant (OHT 8 and 9) 14

 Missing OHTs  Effect on the residue level in pollen and bee products could be reported  Metabolism in fish  Magnitude of residues in fish 15

 Missing OHT on studies reporting residues in honey and bee products  Format and reporting elements of studies reporting residues in honey and bee products in section 6 in IUCLID  It is acknowledged that a test guideline is only in development but not available at OECD level  In absence of OECD guidelines it is difficult to suggest elements of a reporting format, but minimum standards , e.g. information on the test substance, storage conditions for specimen, analytical methods, etc should be reported  The SANTE considers honey as a food of animal origin. In the SANTE technical guidelines for determining the magnitude of pesticide residues in honey and setting Maximum Residue Levels in honey SANTE gives instructions for field residue trials for MRL setting in honey https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_mrl_guidelines_honey.pdf  Place in the current IUCLID structure in section 6 where studies reporting Effect on the residue level in pollen and bee products could be reported  Not appropriate to allocate it under processed commodities, plant residue trials or processed commodities 16  Suggestion to report the study under `other studies` for the moment being