FSIS Directive 5420.1 Food Defense Verification Procedures and National Terrorism Advisory System Alert Response for the Office of Field Operations
PROCEDURES FOR THE OFFICE OF FIELD OPERATIONS
(Part 3)

VII. OBSERVE AND DOCUMENT FOOD DEFENSE VULNERABILITIES

    A. IPP are to document vulnerabilities that are observed while performing a food defense task or during daily inspection activities when there is no evidence of product adulteration. IPP are to document their findings in a Food Defense MOI after discussing their findings with establishment management. IPP are to provide a finalized copy of the Food Defense MOI to establishment management.

    B. IPP are to document Food Defense MOIs by selecting Inspection Verification >> Select Establishment >> Memorandum of Interview from the left toolbar of the PHIS homepage. IPP can also document food defense MOIs when completing a food defense task when saving the inspection task with a non-regulatory concern checked. Once the task is saved, click on the "Create/Edit MOI" button.

        1. To document a domestic OFO Food Defense MOI, click on "Add Food Defense OFO" to open the "Domestic Food Defense MOI" page to access key functions of the MOI.

            a. In the "Status" tab, select attendees with left mouse click on attendee?s name. To select more than one attendee, hold "Ctrl" on keyboard while left clicking on each applicable name;

            b. In the "Category" tab, choose the appropriate potential vulnerability (No product adulteration observed), the occurrence (1st, 2nd, or 3rd), the establishment size (very small, small, or large), and establishment type (meat, poultry, egg products, or equine);

            c. In the "Product" tab, leave this tab blank. Note: IPP in egg product plants will not have the option to select a product type under the "Products" tab;

            d. In either the "Processing" or "Storage" tab, identify the vulnerability point or concern. Note: Additional vulnerabilities, other than those related to processing and storage activities, are available for selection in these tabs;

            e. Check the "Finalize" box and then click "Save" to complete the Food Defense MOI (FSIS Form 5420-1). At the next weekly meeting, provide a finalized copy of the Food Defense MOI to establishment management. Discuss the food defense findings with management, including proposed mitigation actions, and document in the weekly meeting memorandum; and

            f. In the case of a 4th occurrence, IPP are to notify the District Office through supervisory channels.

        2. To document an import Food Defense MOI click on "Add Food Defense OIA" to open the "Import Food Defense MOI" page to access key functions of the MOI.

            a. In the "Status" tab, select category of potential vulnerability (No product adulteration observed), occurrence (1st, 2nd, or 3rd), and attendees with a left mouse click on attendee?s name. To select more than one attendee, hold "Ctrl" on keyboard while left clicking on each applicable name. All other information is automatically filled in;

            b. In the "Product" tab, leave this box blank;

            c. In either the "Processing" or "Storage" tab, indicate the vulnerability point or concern. Note: Additional vulnerabilities, other than those related to processing and storage activities, are available for selection in these tabs;

            d. Check the "Finalize" box and then click "Save" to complete the Food Defense MOI (FSIS Form 5420-1). At the next weekly meeting, provide a finalized copy of the Food Defense MOI to establishment management. Discuss potential mitigation strategies for the vulnerabilities and document the discussion in the weekly meeting memorandum; and

            e. In the case of a 4th occurrence, IPP are to notify the District Office through supervisory channels.

    C. When IPP perform a food defense task or perform other daily inspection activities and find a food defense vulnerability or concern, and there is evidence of product adulteration (e.g., regulatory noncompliance), IPP will schedule and perform a directed Hazard Analysis and Critical Control Point (HACCP), Sanitation Standard Operating Procedures (SOP), Egg Products Food Safety, or other appropriate inspection task to record the observed non-compliance citing the applicable regulation. IPP are to:

        1. Immediately retain the affected product by attaching a retain tag or detain tag, then notify establishment management and discuss the findings;

        2. After informing establishment management, IPP are to report any potentially significant incidents through supervisory channels;

        3. Add the appropriate inspection verification task according to FSIS Directive 13,000.1 to the task calendar, perform the task, and document the observed product contamination in an NR. IPP are to cite the applicable regulation in accordance with FSIS Directive 5000.1,Verifying an Establishment?s Food Safety System or in accordance with FSIS Directive 5030.1; Inspection Methodology Utilizing the Public Health Information System (PHIS) for the Verification of Regulatory Compliance in Egg Products Plants

        4. Complete a Food Defense MOI; and

        5. Immediately provide a finalized copy of the MOI to establishment management and inform management that an NR will also be issued describing the adulterated product and potential vulnerability or concern.

VIII. FOOD DEFENSE TASKS IN FACILITIES PAYING FEES FOR INSPECTION SERVICE

IPP in facilities that only have services as outlined in 9 CFR Parts 350, 351, 352, 354, or 592, are not assigned routine food defense tasks. However, these facilities are encouraged to develop a functional FDP. If the facility requests guidance or additional information on food defense, including how to develop a functional FDP, IPP are to direct establishments to http://www.fsis.usda.gov/fooddefense.

IX. SUPERVISORY RESPONSIBILITIES

    A. "Supervisory personnel" refers to any OFO personnel that supervise IPP who conduct food defense activities.

    B. The supervisor plays a key role in ensuring that decisions made by IPP are consistent with FSIS statutory authority and Agency policy, and that duties are performed in accordance with prescribed inspection methods and procedures addressed in this directive.

    C. FSIS supervisory personnel are to discuss the key points identified in this directive with IPP.

    D. Supervisory personnel are to ensure that IPP are correctly applying the methodology presented in this directive, making informed decisions, properly documenting findings, and taking the appropriate enforcement actions as instructed in this directive.

    E. Supervisory personnel are to refer to the current version of the FSIS Guide for Conducting In-Plant Performance System Assessments for additional guidance and instructions.

X. DATA ANALYSIS

ODIFP will analyze food defense task data, as needed, to determine trends in food defense practices being implemented by establishments. Results will help to inform activities to further protect public health and mitigate food defense vulnerabilities.

XI. QUESTIONS

Refer questions regarding this directive to the Food Defense Assessment Staff by email at FoodDefense@fsis.usda.gov or by telephone at 202-690-6486.


Assistant Administrator
Office of Policy and Program Development
Prior segment of
FSIS Directive 5420.1 (PART 3)