I. PURPOSE

This directive provides instructions to any Office of Field Operations (OFO) inspection program personnel (IPP), including import inspection personnel and egg products inspectors, to discuss topics at the weekly meeting with establishment management that are pertinent to an establishment’s food safety system and that could affect public health. To assist IPP, this directive provides a general list of food safety related topics that they should consider for discussion during weekly meetings.

NOTE: For the purposes of this directive, use of the term, “establishment” will refer to meat and poultry establishments, egg products plants, and official import establishments.

KEY POINTS:

• Incorporate instructions for egg products inspectors
• Describes the purpose of the weekly meeting
• Provides a list of possible topics of discussion
• Addresses the preparation of the Memorandum of Interview (MOI)
• Addresses the responsibilities of Supervisory Personnel

II. REASON FOR REISSUANCE

A. This directive is being reissued to include information related to conducting weekly meetings in establishments operating under the Public Health Inspection System (PHIS), to include as possible topics for discussion during the weekly meeting: 1) establishment pathogen test results and 2) issues of concern to establishments also under Food and Drug Administration (FDA) jurisdiction; to update information links and modify Section VII regarding the preparation of the Memorandum of Interview (MOI); and to add a section addressing Supervisory responsibilities.

B. This directive is also being reissued to incorporate information previously published in FSIS Notice 49-13, Conducting Weekly Meetings in Egg Products Plants in order to include inspection personnel assigned to egg products plants.

III. WEEKLY MEETING

A. The purpose of the weekly meeting is to provide an opportunity for IPP to bring matters that bear on the establishment’s on-going compliance with FSIS requirements to the attention of establishment management. These meetings should benefit both IPP and the establishment. However, discussion of issues during the weekly meeting is not intended to replace documentation of noncompliance. Moreover, the fact that an issue is not discussed at the weekly meeting does not mean that the issue could not become the subject of a noncompliance record.

B. As set out in FSIS Directive 5000.1, Verifying an Establishment’s Food Safety System and FSIS Directive 5030.1, Inspection Methodology Utilizing PHIS for the Verification of Regulatory Compliance in Egg Products Plants, IPP are to conduct weekly meetings with establishment management to discuss topics that could affect food safety and the establishment’s ability to meet regulatory requirements.

C. A wide variety of topics can be discussed at the meetings, including individual noncompliances and developing trends of noncompliance. They are an opportunity for establishments to share information regarding their operations, such as facility improvements and changes to their food safety systems. Weekly meetings also afford FSIS an opportunity to inform establishments of topics of discussion that could include findings that are not regulatory noncompliances (e.g., less than perfect conditions) but that could, over time, become noncompliances.

D. In addition, there can be discussion of information from external sources, such as customer or consumer complaints, that can provide information to alert establishment management about a safety risk or about other information that is relevant to the establishment’s food safety system.

E. The following list provides some example topics that IPP may discuss at the weekly meeting. The list is not comprehensive and is not intended to act as a checklist. More importantly, IPP, including egg inspection personnel, and import inspection personnel are to communicate with the establishment about any topics that relate to food safety and that could affect public heath.

F. Possible topics for discussion include:

1. In-plant observations, including, but not limited to:

• a. Individual Noncompliance Records (NR);
• b. Developing trends of noncompliance (e.g., discuss any identified associations between current and past noncompliances);
• c. FSIS findings that do not rise to the level of noncompliance but that warrant discussion (e.g., less than perfect conditions that may, if not addressed, become noncompliances);
• d. Humane handling issues, including those that do not rise to the level of noncompliance but warrant discussion;
• e. Issues related to the implementation and verification of Less Than Daily Sanitation procedures; and
• f. Potential Food Security issues

2. Issues of concern and information that the establishment wishes to share;

3. Agency issuances, for example, but not limited to:

• a. Policy clarifications published in askFSIS;
• b. New, revised, or amended FSIS Directives, FSIS Notices, FSIS Compliance Guides; and Import and Export policies;
• c. New Policy Points PowerPoint presentations that promote a uniform understanding of FSIS issuances; and
• d. Small and very small plant outreach information

4. Information regarding FSIS sampling:

• a. Results received through Laboratory Information Management System-Direct (LIMS-Direct);
• b. Changes to Products and Product Volumes in the Plant Profile;
• c. E.coli O157:H7 results, also available through the Constituent Update, posted on the Microbiological Testing Program for Escherichia coli O157:H7 and non-O157 Shiga toxin-producing Escherichia coli (STEC) website;
• d. Salmonella results, also available through the Constituent Update, posted on the Salmonella Verification Testing Program: Monthly reports for Establishments by Performance Category website;
• e. Notification through LIMS-Direct of violative residue sample results, or import port of entry sample violations and information posted on the FSIS Repeat Violator List for Use by FSIS Personnel and the FSIS Repeat Violator List for Use by Livestock Markets and Establishments; and
• f. Notification that Routine Risk Based Listeria monocytogenes (RLm) and Intensified Verification Testing (IVT) testing will be conducted as a result of a positive Listeria monocytogenes sample in Ready- to-Eat product.

5. Information related to the establishment’s food safety system, for example, but not limited, to:

• a. Establishment testing results, observed in accordance with the instructions in FSIS Directive 5000.2, Review of Establishment Testing Data by Inspection Program Personnel, that indicate possible changes (e.g., an increase in the presence of enteric pathogens of human health concern such as Listeria spp., Salmonella spp., E. coli O157:H7, or Campylobacter);
• b. Implementation of, and changes to, any of the establishment’s prerequisite programs (e.g., Allergen controls, Specified Risk Materials, Certificates of Analysis) that are in place to support food safety decisions;
• c. Changes to the establishment’s food safety or production practices, including changes to the product line, processing methods used, product flow, sanitation measures, equipment configuration, or treatment of product, that could impact the establishment’s food safety system;
• d. New Technology Summaries (i.e., “No Objection” letters), available to IPP through the FSIS Intranet, that may help the establishment improve food safety. This discussion would include a mutual understanding of specific process parameters or critical limits that are part of these “no objection” letters;
• e. Changes in in-plant regulatory waivers or new technology trials; and
• f. Changes to facility or equipment.

6. Information from external sources such as:

• a. Complaints from consumers or establishment customers (e.g., institutions such as hospitals or nursing homes, restaurants, schools, grocery stores, distributors, or wholesalers), if available; and
• b. Current Recalls, including those that have involved product received by the establishment, product similar to product produced by the establishment, or product held for re-inspection by FSIS at an import establishment. Further areas for discussion may include:

i. Any required follow-up FSIS testing or increased or intensified testing on imported products;

ii. Any establishment testing of imported products;

iii. Any planned actions associated with the recalled product that has been received by the establishment; and

iv. Discussion with plant management regarding how it can use information from recalls of products similar to those produced at the establishment as a mechanism to improve its own operation.

7. Discussion of FSIS’ role in Dual Jurisdiction Establishments (DJE) as addressed in FSIS Directive 5730.1 Responsibilities in Dual Jurisdiction Establishments. Further areas for discussion with DJEs may include:

• a. Recalls of Food and Drug Administration (FDA) products that may affect FSIS regulated product (e.g., by being used as an ingredient);
• b. Positive Listeria monocytogenes sample results of FDA regulated products that may affect FSIS regulated product and visa versa; and
• c. Allergen issues related to FDA regulated product that may affect FSIS regulated product.

8. Discussion of issues related to changes in operating schedules.

IV. PREPARING THE MEMORANDUM OF INTERVIEW (MOI)

A. The FSIS employee who attends the weekly meeting is to take notes of the meeting and is to document those notes in a Memorandum of Interview (MOI) in accordance with the instructions in FSIS Directive 5000.1 and FSIS Directive 5030.1.

NOTE: In the event that no issues are identified for discussion at the weekly meeting, IPP are to document that fact on the MOI and provide a copy of the MOI to establishment management.

B. Establishment management is not obligated by regulation to attend or participate in weekly meetings. If, after notification by IPP that FSIS will be conducting weekly meetings at a mutually agreed to time and location, plant management refuses to attend or to participate, IPP are to document that fact on the MOI and provide a copy of the MOI to plant management. IPP are also to notify their immediate supervisor of the establishment’s decision not to meet.

NOTE: If the need arises, IPP are to work with establishment management to reschedule the meeting so that it is mutually convenient to both FSIS and plant management.

C. In multi-inspector/multi-shift plants, it is the responsibility and duty of the Inspectors-in-Charge (IICs) to conduct and document weekly meetings. IICs are to ensure that any potential regulatory concerns that arise on any shift are discussed at the meeting. IICs may delegate the responsibility of conducting the meeting or may run the weekly meeting and include IPP in the meeting with plant management; however, the MOI is to be signed by the IIC. The IIC is to ensure that all IPP on all establishment shifts are made aware of regulatory concerns that are discussed at weekly meetings.

D. IPP are to provide a copy of the MOI to the establishment management and are to maintain a copy, either electronically in PHIS or the government file.

E. IPP are to advise the establishment that if it objects to the content of the MOI, it may document its concerns or disagreement in several ways, specifically;

1. Through PHIS. If the establishment chooses to use PHIS, IPP are to advise establishment management that information regarding how to access PHIS is available in the Establishment Management User Guide , Section 3.1.1.2, Plant Management: How to respond to a Memorandum of Interview (pages 25-28)
2. By informing the inspector, either orally or in writing. If the objection is presented orally, IPP are to document the objection on the MOI, or if presented in writing, IPP are to attach the objections to the MOI. IPP are to reference the attachment in the MOI and provide a copy to plant management; or
3. Establishment management can also elect to bring their objections to the attention of other agency officials in the supervisory chain.

V. SUPERVISORY PERSONNEL RESPONSIBILITIES

NOTE: For the purposes of this directive, “Supervisory Personnel” refers to any OFO personnel who have supervisory responsibilities of in-plant IPP.

A. The supervisory personnel play 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 the information and procedures addressed in this directive.

B. Supervisory personnel are to discuss the key points identified in this directive with IPP and are to clarify any issues of concern.

C. Supervisory personnel are to ensure that IPP are:

1. Conducting the weekly meetings in accordance with the instructions in FSIS Directive 5000.1 and FSIS Directive 5030.1.
2. Addressing relevant issues such as those listed in Part III, Paragraph F of this directive; and
3. Properly documenting the meeting in an MOI. Supervisory personnel are to review the MOIs when they become available.

D. Supervisory personnel are to refer to the current version of FSIS Directive 4430.3, In-Plant Performance System (IPPS) for additional guidance and instructions.

VI. QUESTIONS

Refer questions regarding this directive to the Policy Development Staff through askFSIS or by telephone at 1-800-233-3935. When submitting a question, use the Submit a Question tab, and enter the following information in the fields provided:

• Subject Field: Enter Directive 5010.1
• Question Field: Enter your question with as much detail as possible.
• Product Field: Select General Inspection Policy from the drop-down menu.
• Category Field: Select Regulations/Agency Issuances from the drop-down menu.
• Policy Arena: Select Domestic (U.S.) only from the drop-down menu.

When all fields are complete, press Continue and at the next screen press Finish Submitting Question.