2019 Vet Drug Residues ERP - Review Book

3. Is there information demonstrating that the

As mentioned above in II.1 of this review report, many of the residues listed in Table 1 of the SMPR are included in the scope of the methods submitted. However, the list of analytes covered by the submitted methods and those listed in the SMPR do not match completely. There are many pesticides listed in the SMPR Table that are not included in methods described in this submission. Although, some pesticides might have been included in the “multi-family” method, others especially the pyrethroids, would most likely require an additional method stream. Because published methods are available which cover a larger scope of pesticides in these matrices, this submission is justifiably more focused on veterinary drug residues. Some explanation might be needed as to why some of the drugs with MRLs for poultry were not considered since chicken is included in the scope of validated matrices. Also, as mentioned previously, some drug metabolites listed on the SMPR are not included. In general, this is not a critical gap if the analytes selected adequately capture the potential incidence of contamination with drug residues. For example, it may not be necessary to include all the listed metabolites of albendazole. However, in other instances, the lack of a drug metabolite that may act as the marker residue (e.g. florfenicol amine) could result in missed non- compliant samples. For the analytes that were chosen to be included in this suite of methods, the vast majority met the performance characteristics specified in the submission. Only a few (3) compounds in the multi-family did not meet these criteria, and these analytes were removed from the scope. No additional precautionary statements were needed regarding safety. Critical steps in the method were adequately described in the detailed analytical flow sheets for each method stream. Some additional information regarding sample through-put would be useful. For each method stream, Section 10.5 specifies the time of analysis required for each batch of 20 samples (30-48 hours for each stream). In addition, knowing how many different LC-MS/MS instruments and how many analysts are required to run a sample set by all 4 method streams would allow a laboratory to allocate the necessary resources to implement these methods. The hormones listed in the SMPR, especially those with low MRLs, might also be difficult to include in the multi-residue method.

method performs within the SMPR Method Performance REquirements table specifications for all analytes in the SMPR applicability statement? If not, please specify what is missing and whether or not the method's applicability should be modified.

IV. General Submission Package 1. Based on the supporting information, were there any additional steps in the evaluation of the method that indicated the need for any additional precautionary statements in the method?