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2. Tier 2
a. Inspector-Generated Sampling
FSIS inspection program personnel (IPP) conduct inspector-generated sampling when they suspect that
animals may have violative levels of chemical residues. Currently, inspector-generated sampling targets
individual suspect animals, suspect populations of animals, and animals condemned for specific
pathologies listed in FSIS Directive 10,800.1, Rev 1
. When Public Health Veterinarians (PHVs) detect
evidence of a disease that may have been treated or suspect the administration of a drug, they retain the
carcass and analyze samples from those carcasses using an in-plant method to screen for the presence of
chemical residues. If the in-plant test is negative for antimicrobial residues included in the screen, the
carcass is released to the establishment. If there are screen positive results, the carcass is held pending the
results of laboratory testing. The PHV condemns carcasses of animals found to contain violative levels of
residues in the muscle or if an unapproved drug is detected in any tissue.
In 2016, IPP completed in-plant residue screens using the Kidney Inhibition Swab test (KIS™ test). The
screen positive samples are submitted to the FSIS Midwestern Laboratory and analyzed by the laboratory
to identify, quantify and confirm the contaminants.
i. Sampling of Individual Suspect Animals
Under the direction of the PHV, IPP are to conduct a KIS™ test on any carcass that based on herd history
or ante-mortem or post-mortem findings inspection findings may contain a violative drug residue. IPP are
to follow the instructions provided in Directive 10,800.1, Rev 1
, chapter three for circumstances
warranting a KIS ™ test and Chapter Four for performing KIS™ tests and documenting the task in PHIS.
The PHV selects a carcass for sampling based on the criteria outlined in
FSIS Directive 10,800.1, Rev 1
(i.e., animal with disease signs and symptoms, producer history, or as a follow-up to results from random
scheduled sampling). Usually, the sample is screened in the plant by the IPP and the screen-result verified
when necessary by a PHV. Other samples are sent directly to the laboratory for analysis. For example, if
the IPP suspects the misuse of a veterinary drug in an animal, she/he can perform the relevant in-plant
screening analysis. If the result of a screening analysis is positive, the carcass is held (if it is not already
condemned for other pathology or conditions that would make it unfit for human consumption), and the
liver, kidney, and muscle samples from the carcass are then sent to an FSIS laboratory for analysis and
confirmation.
ii. Sampling of Suspect Animal Populations
Sampling for suspect animal populations is directed by an FSIS regulation (9 CFR 310.21) and
Directive
10,800.1, Rev 1. This is outlined for healthy appearing bob veal calves and show animals.
b. Targeted Sampling
FSIS implements targeted sampling plans (exploratory assessments) in response to information (obtained
by FDA and EPA and provided to FSIS) about misuse of animal drugs and/or exposure to environmental
chemicals, as well as in response to Tier 1 analytical results. The duration of these sampling plans vary
based on the situation. FSIS may conduct studies to develop information on the frequency and
concentration at which some residues like trace metals and industrial components may be inadvertently
present in animals. These sampling plans could be designed to distinguish components of meat, poultry
and egg products in which residue problems exist, to measure the extent of problems, and to evaluate the
impact of actions taken to reduce the occurrence of residues in the food animal population.
Sampling tasks are assigned through PHIS. The sampling task provides instructions to the IPP on when
to collect the sample (collection window) and which slaughter production class to collect from. The
establishment holds or controls livestock carcasses selected for testing pending the test results. For