This notice informs inspection program personnel (IPP) that, starting July 20, 2009, the Agency will begin to replace the Fast Antimicrobial Screen Test (FAST) with the Kidney Inhibition Swab (KISTM) Test. This replacement will take place in phases. The first phase will involve 101 designated cattle slaughter establishments. Carcasses for sampling and testing by KISTM will be selected in the same way as for FAST; see FSIS Directive 10,800.1, "Procedures for Residue Sampling, Testing, and Other Responsibilities for The National Residue Program"
After initial implementation of KISTM, FSIS will allow a brief period for feedback and then continue with implementation at the remaining cattle slaughter establishments. Until further notice, FAST will continue to be used at the selected establishments for livestock other than cattle and at all other establishments where FAST is currently in use.
District Veterinary Medical Specialists (DVMSs) are to oversee all phases of KISTM implementation at the selected cattle slaughter establishments in their Districts. The DVMSs are to notify the Front Line Supervisors (FLSs) and the Inspectors in Charge (IICs) at the establishments at which KISTM will be implemented. The IICs are to assign IPP to conduct the tests as needed. Both Public Health Veterinarians (PHVs) and Consumer Safety Inspectors (CSIs) perform the FAST. Therefore, when the KISTM test is implemented, either PHVs or CSIs may be assigned to conduct this test.
KISTM Test training materials on "Performing the KISTM Test" in both CD-ROM and written formats will be sent from the FSIS Midwestern Laboratory to IICs at the selected slaughter establishments to arrive by July 15, 2009. The IICs at the slaughter establishments at which KISTM will be initially implemented are to provide the training materials to those designated by the IIC to conduct the test. Immediately after reviewing both the "Performing the KISTM Test" CD-ROM and written instructional booklet, those designated to conduct the test are to log onto AgLearn and affirm completion of the KISTM training. Any IIC at a selected establishment who has not received training materials by July 15, 2009, should contact Louise Hsu at firstname.lastname@example.org and request the training materials.
Receipt of Test Supplies
IICs at the establishments at which KIS will be first implemented will receive KISTM test supplies, including heating blocks, by July 15, 2009. Those IICs are to begin using KISTM for cattle as soon as IPP designated to conduct the test have completed the training but not before July 20, 2009.
In time KISTM will replace FAST for all livestock. FSIS will then phase out all FAST incubators and supplies and provide instructions on appropriate disposition. Until then, IICs at establishments selected for the first phase of KISTM implementation that slaughter other livestock in addition to cattle are to maintain both KISTM and FAST supplies. IICs at establishments selected for the first phase of KISTM implementation that no longer need the FAST incubator are to contact the Accountable Property Officer at the District Office for instructions on how to handle the excess equipment and to arrange for proper disposition.
Note that some older incubators may still contain mercury thermometers, which can be identified by their silver or metallic colored indicator material. Mercury is a toxic material subject to many regulations for recycling, disposal, transportation, and shipping. All unbroken mercury thermometers are to be returned to the Midwestern Laboratory. New non-mercury thermometers will be provided for incubators that are still in use. For instructions on how to obtain proper packing and shipping materials, where to send unbroken mercury thermometers, and how to request non-mercury thermometers, contact Kathy Holland at the FSIS Midwestern Laboratory at email@example.com. If a mercury thermometer is broken, it is hazardous waste that requires special handling and is not to be shipped to the Midwestern Laboratory. Instead, contact the FSIS Environmental Manager, Laurie Segna, at firstname.lastname@example.org, for additional instructions on mercury spill clean up and hazardous waste labeling, storage, and disposal.
Additional FAST and KISTM supplies can be obtained from the FSIS Midwestern Laboratory (mailbox for sampling supplies: SamplingSupplies-MidwesternLab@fsis.usda.gov or in Outlook: Sampling Supplies-Midwestern Laboratory). The following is the list of KISTM supplies available from the Midwestern Laboratory:
» Digital Dry Block Heater (tests 20 units)
» KISTM (Kidney Inhibition Swab) Tests (in packs of 25 tests)
» Negative Controls (4 tablets (approximately for 1 month testing, as each reconstituted tablet is good for 5 days)
» 15 ml Tube of deionized or distilled water (or equivalent)
» Transfer Pipettes (in packs of 25-approximately for 1 month testing) or equivalent device for delivering 1ml of water
» Test Tube Rack (or equivalent device, to hold the KISTM tests)
When requesting supplies, IICs are to include the establishment number, mailing address, and the specific supplies needed.
In-Plant Procedure and Decision Responsibility
In-plant PHVs will be responsible for conducting the test or supervising a CSI assigned to conduct the test. As both PHVs and CSIs routinely perform the FAST, the KISTM test may be performed by PHVs or CSIs.
The PHV or CSI conducting the test is to read the results between 3 and 16 hours after incubation. The results for this KISTM test are based on distinct color changes. If the KISTM test is positive, the PHV/CSI is to send the sample to the laboratory for confirmation and hold the carcass for disposition. The PHV/CSI is to follow the directions in FSIS Notice 39-09 Electronic Sample (eSample) Phase I- Reporting In-plant Test Results, for reporting the results from both the KISTM and FAST in-plant tests. FSIS Form 6600-7, FAST Antimicrobial Screen Test Worksheet is not to be used to report test results for KISTM. The CSI may print out an eSample report of samples tested for the PHV if necessary.
In cases where there is doubt as to the test outcome, and there is no in-plant PHV, the CSI performing the test will take a digital picture and send it to the PHV assigned to cover that establishment for final determination of the test reading. In those Districts or establishments where digital cameras are not available, in case of an unclear reading of the KISTM test, the PHV assigned to cover that establishment will verify the results.
Action on retained carcass disposition will be dictated by FSIS laboratory results, if the carcass is not already condemned for other pathology. Carcass condemnation following a KISTM test will remain the responsibility of the PHV, based on FSIS laboratory results.
In order to monitor operational performance, effectiveness of program implementation, and scientific outputs of the drug residue program, the Office of Data Integration and Food Protection (ODIFP) and the Office of Public Health Science (OPHS) will analyze data from the in-plant KISTM tests. ODIFP will evaluate program effectiveness and operational performance on a monthly basis and will analyze sample collection and analysis rates nationally and by district and circuit. In addition, ODIFP will analyze the number of confirmed positive KISTM test results and will evaluate the relationship between KISTM test results and establishment condemnation rates. OPHS, in conjunction with the Risk and Innovations Management Division of the Office of Policy and Program Development (OPPD), will use KISTM test results to design the veterinary drugs part of the National Residue Program, in collaboration with the Food and Drug Administration (FDA). OPHS and OPPD will also take the KISTM test results into account in collaborating with FDA on drug residue enforcement matters, including the Repeat Violator Information System (RVIS).
Direct all technical questions to the Policy Development Division and all sampling questions to the Risk Innovation and Management Division at 1-800-233-3935 or submit your questions through askFSIS at http://askfsis.custhelp.com.
Office of Policy and Program Development