On-farm HACCP (hazard analysis critical control points) monitoring requires cost-effective, yet accurate and reproducible tests that can determine the status of cows, milk, and the dairy environment. Tests need to be field-validated, and their limitations need to be established so that appropriate screening strategies can be initiated and test results can be rationally interpreted. For infections and residues of low prevalence, tests or testing strategies that are highly specific help to minimize false-positive results and excessive costs to the dairy industry. The determination of the numbers of samples to be tested in HACCP monitoring programs depends on the specific purpose of the test and the likely prevalence of the agent or residue at the critical control point. The absence of positive samples from a herd test should not be interpreted as freedom from a particular agent or residue unless the entire herd has been tested with a test that is 100% sensitive. The current lack of field-validated tests for most of the chemical and infectious agents of concern makes it difficult to ensure that the stated goals of HACCP programs are consistently achieved.