NOTE: DO NOT IMPLEMENT THIS DIRECTIVE UNTIL APRIL 1, 2017. INSPECTION PROGRAM PERSONNEL ARE ALLOWED ONE HOUR OF OFFICIAL TIME TO READ THIS DIRECTIVE.

I. PURPOSE

This directive provides instructions to conduct food defense activities assigned to inspection program personnel (IPP) at meat and poultry establishments, egg product plants, and import inspection establishments. Food defense activities include performing food defense tasks and observing and reporting food defense vulnerabilities. This directive also outlines the internal FSIS communication protocol for threats to the food and agriculture sector.

NOTE: In the Public Health Information System (PHIS), the word “establishment” appears for meat, poultry, and import inspection establishments, as well as egg products plants.

II. CANCELLATION

FSIS Directive 5420.1, Revision 9, Food Defense Verification Tasks and Threat Notification Response Procedures for the Office of Field Operations, 10/19/15

III. SIGNIFICANT CHANGES

Significant changes in this directive include removal of the annual food defense plan (FDP) survey and modification of frequency and content for food defense tasks. IPP will no longer perform four food defense tasks per month, but instead will perform one comprehensive food defense task per quarter. These changes will improve efficiency for IPP and will enhance data quality by providing more specific data on food defense practices being implemented by establishments.

IV. BACKGROUND

A. Food defense is the protection of food products from contamination or adulteration intended to cause public health harm or economic disruption. FSIS promotes food defense by encouraging establishments to voluntarily adopt a functional FDP, implement food defense practices, and conduct training and exercises to ensure preparedness. Food defense practices are policies, procedures, or countermeasures to mitigate vulnerability to intentional contamination. IPP perform food defense tasks to identify vulnerabilities within establishments that may lead to intentional contamination of FSIS-regulated product.

B. A functional FDP can help an establishment prevent, protect against, mitigate, respond to, and recover from an intentional contamination incident. The absence of a functional FDP may increase an establishment’s vulnerability to intentional contamination because important security measures needed to protect the facility, product, and employees may not be in place. Functional FDPs are voluntary in official FSIS-regulated establishments (i.e., not mandated by regulation); however, FSIS encourages establishments to adopt a functional FDP to further protect their product. If establishments choose to develop a functional FDP, they are not required to share it with IPP.

V. NOTIFICATION OF THREAT FROM INTELLIGENCE COMMUNITY

A. IPP are to know the protocol for communicating threat information related to the food and agriculture sector to establishment management through proper supervisory channels as necessary. Threat information from the intelligence community is to be communicated through the following:

1. The FSIS Office of Data Integration and Food Protection (ODIFP) Assistant Administrator (AA) or designee is the primary point of contact for receipt of threat information from the intelligence community;
2. If a threat has the potential or is expected to affect food or agriculture, the ODIFP AA or designee is to inform the FSIS Administrator and FSIS Management Council;
3. The ODIFP AA or designee is to determine the appropriate distribution of the threat information and coordinate with the FSIS Office of Field Operations (OFO), Office of Investigation, Enforcement and Audit (OIEA), the Office of Public Affairs and Consumer Education (OPACE), and the Office of Public Health Science (OPHS) to notify employees, stakeholders, and the public, as appropriate; and
4. In the event of a significant incident, the FSIS Emergency Management Committee may be alerted or activated and other response actions taken pursuant to FSIS Directive 5500.2, Significant Incident Response.

B. Supervisory personnel are to ensure that any notifications distributed to field employees pursuant to this directive are available to IPP in the establishment.

C. As soon as supervisory personnel are notified of threat information, they are to inform establishment management of the alert. IPP are to document their discussion with establishment management in a memorandum of interview (MOI) (see FSIS Directive 5010.1, Food Safety Related Topics During Weekly Meetings).

D. ODIFP is to notify the FSIS Administrator and the FSIS Management Council of any changes in threat information, to include when the period of concern has expired. ODIFP is to coordinate with OFO, OIEA, OPACE, and OPHS to notify employees, stakeholders, and the public, as appropriate. Supervisory personnel are to advise other IPP in the establishment and establishment management of the change in threat status.

E. If IPP observe a potentially significant incident that presents a grave, or potentially grave, threat to public health or to the safety of FSIS-regulated product or to personnel, they are to report it through supervisory channels. IPP are to follow instructions provided in FSIS Directive 5500.2, which also lists examples of significant incidents.

VI. PERFORMING FOOD DEFENSE TASKS IN PHIS

A. IPP are to perform food defense tasks as assigned in PHIS. PHIS will automatically generate one routine food defense task per quarter to the establishment task list. Inspectors-in-charge (IICs) assigned to multi-inspector, multi-shift establishments are to use the established information-sharing practices to ensure that they perform the food defense task at the prescribed frequency. The Frontline Supervisor (FLS) is to provide any necessary oversight.

B. The table below lists the questions associated with the food defense task. The examples of food defense practices provided in the table are not all-inclusive. Establishments can implement a variety of food defense measures to protect their products, people, and processes from intentional contamination. Food defense is not a one-size-fits-all approach. IPP are to consider this when performing the food defense task. In addition, some food defense activities may not be obvious to IPP. Therefore, IPP are to discuss these activities with management during a weekly meeting to learn more about the establishment’s food defense practices. Establishments are to use the FSIS Food Defense Risk Mitigation Tool to find a more comprehensive list of food defense practices (mitigation strategies). If IPP have questions regarding this task, they are to direct them to their immediate supervisor.

C. IPP are to answer all the questions in the food defense PHIS questionnaire as either “Yes”, “No”, or “not applicable” (“N/A”). IPP are not to leave questions blank.

D. As IPP are completing the task, they are to be aware that food defense practices are policies, procedures, or countermeasures to mitigate vulnerability to intentional contamination. An establishment does not have to implement multiple food defense practices in order for IPP to answer “Yes” to the task questions. IPP are to answer “Yes” to the question if one or more of the examples of food defense practices are implemented or if there is another mitigation strategy to address the potential vulnerability. If IPP have questions as to the appropriateness of a mitigation strategy that is not listed as an example, they are to direct these questions to their immediate supervisor.

E. Not all tasks may be applicable to all establishment types. If a task does not apply to their establishment, IPP are to answer “N/A”.

F. IPP are to try to observe as many of the food defense practices as possible. However, if IPP do not know the answer to a question, they are to discuss the question with establishment management at a weekly meeting. The establishment is not required to disclose information about its food defense practices to IPP. IPP are not to issue a Noncompliance Record (NR) if the establishment chooses to withhold information. If IPP do not know the answer to a question and are unable to verify the answer with establishment management, they are to answer it as “N/A”.

G. If IPP are unclear as to how to conduct the food defense task or have questions about the task, they are to contact their immediate supervisor. Supervisors seeking support or guidance are to submit questions to the Food Defense Assessment Staff at FoodDefense@fsis.usda.gov.

See full PDF for Table

H. To access and complete the PHIS task questionnaire, IPP are to:

1. Look for “Food Defense Task” on the establishment task list and schedule it on their task calendar, then claim the task when they are ready to conduct the task;
2. Select the “Activity” tab, then select the applicable Verification Activity (Review & Observation, Record Keeping, or Both);
3. Select the “Questionnaire” tab. Click on “Take Questionnaire” tab to access the questions;
4. Click “Start” to begin questionnaire;
5. Select answers to questions on page one. Click “Next” and proceed to the next page of questions. IPP are to complete all questions and are not to leave any blank or unanswered. IPP are to select “N/A” if the question does not apply to the establishment;
6. Click "Submit” to complete the questionnaire; and
7. Record the task as completed after the questionnaire results have been entered.

I. IPP are to review the answers of the questionnaire with establishment management in the weekly meeting following task completion. Based on the questionnaire answers, IPP are to discuss areas in the establishment where a food defense vulnerability exists and mitigation strategies to address identified vulnerabilities and weaknesses in the establishment. IPP can find examples of common food defense mitigation strategies in FSIS’ Food Defense Risk Mitigation Tool.

J. When a threat notification is issued, the IIC is to receive specific instructions through supervisory channels on other actions, if any, that he or she is to take based on information received about the specific threat to a product or process. If additional food defense tasks are necessary, IPP are to follow the instructions in FSIS Directive 13,000.1, Scheduling In-Plant Inspection Tasks in the Public Health Information System (PHIS), when scheduling a directed PHIS task.

K. If the establishment requests guidance or additional information on food defense, including how to develop a functional food defense plan, IPP are to direct establishments to http://www.fsis.usda.gov/fooddefense. The food defense website contains guidance documents and tools to assist establishments with food defense practices (e.g., a general FDP template, brochures, guides, and fact sheets). Many of these materials are available in multiple languages. If the establishment needs a copy of a FDP template or other food defense resources, IPP are to provide the name and mailing address of the establishment to the Office of Outreach, Employee Education and Training Small Plant Help Desk by email at Infosource@fsis.usda.gov or call 1-877-374-7435, and the materials will be mailed. Alternatively, IPP may download a copy of the General Food Defense Plan from the FSIS website at http://www.fsis.usda.gov/fooddefense.

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 non-compliance), 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.