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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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      8-4-1 - Alert
      8-4-2 - Presumptive
      8-4-3 - Confirmed
      8-4-4 - Termination Of Emergency Investigation


Various terms (i.e., alert, case, suspect, preliminary, etc.) have been used in describing the status of a sample analysis or the stage of an investigation. This has led to confusion and misinterpretation in the identification and management of emergency situations. The following terminology will be used to describe the status of a notification of an emergency:

  8-4-1 - Alert

Information without support. An alert should be made when the following type of information is received:

  1. Unconfirmed report of product related illness/injury or unanticipated adverse reaction;
  2. Unconfirmed report of the presence of a toxic (chemical, radioactive, or microbial) substance; or,
  3. A report of a man-made disaster (oil spill, radiological accident) or a natural disaster (hurricane, flood, tornado).
  4. Confirmation of declaration of pandemic influenza (WHO) Phases 4, 5, and 6; US Government Response Stages 2, 3, 4, and 5.

  8-4-2 - Presumptive

Information (analytical, inspectional, investigational, etc.) strongly suggests that a problem exists. Presumptive may be used to describe situations which include the following:

  1. Epidemiological data has provided a significant association between the illness, injury, or unanticipated adverse reactions and the product;
  2. An original analysis by a reliable laboratory has revealed a significant level of a toxic chemical, radioactive material, or microbial substance in a regulated product, but confirmation is not complete;
  3. An oil spill has drifted into fishing areas;
  4. A radiological incident has occurred and radioactive material has been released, but the extent is unknown; or,
  5. Floods have caused property damage in an area where regulated products are being held.
  6. Confirmation of widespread outbreak in multiple locations overseas (WHO Phase 6; US Government Response Stage 3).

  8-4-3 - Confirmed

A problem has been confirmed through laboratory analyses, field investigations, analysis of epidemiological data or a combination of these. Information received from another governmental agency or other source known to be reliable may be accepted for confirmation purposes. The first human case of pandemic influenza in U.S. is confirmed (WHO Phase 6; US Government Response Stage 4).

  8-4-4 - Termination Of Emergency Investigation

When it is not possible to obtain information confirming that an emergency situation exists, emergency investigations may be terminated at the Alert or the Presumptive stages. However, in all cases, the EOC will attempt to identify the source and scope of the problem, given the hazard involved. The depth and extent of FDA activities, at the confirmation of an emergency situation, is based on factors such as:

  1. interstate distribution of involved product, and/or,
  2. other Federal, state, or local government efforts to control the problem.

When other Federal, state, or local agencies can more effectively deal with a problem, FDA will terminate its emergency investigation, at which time ad hoc emergency teams or units established under this procedure may be phased out by EOC. EOC contact should be maintained with the investigating agency until a conclusion is reached. Following completion of an FDA emergency investigation, ad hoc emergency teams or units established under this procedure may be phased out after consultation with the EOC.