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Inspection Coverage for Reimbursable Overtime Inspection and Operations Occurring Without Required Inspection Services

FSIS directive 12800.1
Series Type 12000 Series: Voluntary Inspection
Issue Date Feb 13, 2025
Full Directive
12800.1.pdf
  1. PURPOSE
    This is a new directive that combines the instructions in FSIS Directive 12600.2, Reimbursable Overtime Inspection Services for Meat, Poultry, and Egg Products, and FSIS Directive 12700.1, Operations Occurring Outside Approved Hours. This directive provides instructions to inspection program personnel (IPP) on operations that require, or do not require, overtime inspection services and how to provide inspection services during reimbursable overtime periods. Additionally, this directive includes instructions for IPP and the District Manager (DM) on how to respond when an official establishment conducts operations or activities without required inspection coverage, including outside the approved hours or outside the limits of the establishment's approved premises.

    KEY POINTS:
    • Describes activities conducted at official establishments that require inspection coverage, including during reimbursable overtime periods
    • Describes activities conducted at official establishments that do not require overtime inspection coverage
    • Instructs IPP on who to notify when an establishment operates without inspection coverage
    • Describes appropriate control and disposition of products produced without required inspection
  2. CANCELLATION
    FSIS Directive 12,600.2, Rev. 3, Reimbursable Overtime Inspection Services for Meat, Poultry, and Egg Products, 1/27/23

    FSIS Directive 12,700.1, Rev. 1, Operations Occurring Outside Approved Hours, 11/25/08
  3. BACKGROUND
    1. The Federal Meat Inspection Act (21 U.S.C. 610(c)(2)), Poultry Products Inspection Act (21 U.S.C. 458(a)(2)(B)), and Egg Products Inspection Act (21 U.S.C. 1037(b)(2)), prohibit the sale, offering for sale or transportation, or receipt for transportation, in commerce, of any article required to be inspected, unless the article has been inspected and passed or is exempt from the inspection requirements of the statutes.
    2. FSIS regulations 9 CFR 307.4, 381.37, 533.5, and 590.24 provide that no operations requiring inspection shall be conducted except under the supervision of a program employee. FSIS provides these inspection services to official establishments without charge during approved hours of operation. These regulations further provide that each official establishment is to submit proposed hours of operation to the DM for approval. Additionally, the DM, or designee, approves the limits of the official establishment's premises in accordance with 9 CFR 304.2(a) for meat, 381.20(b) for poultry, or 590.146(b) for egg products.
    3. FSIS requires establishments, importers, and exporters to reimburse the Agency for the cost of inspection services furnished on Federal holidays and outside of approved hours of operation. The Agency, in 9 CFR 307.6, 381.39, 533.7, and 590.130, establishes the basis for billing overtime services, 2-hour callback requirements, and that billing is performed in quarter hour increments. Inspection services in egg products establishments are considered overtime as described in 9 CFR 590.126 when operations in an official plant require the services of IPP beyond their regularly assigned tour of duty on any day or on a day outside the established schedule. Sec. 730 of the Consolidated Appropriations Act, 2024, allows FSIS to charge meat, poultry, and egg products establishments for the cost of inspection services provided outside of an establishment's approved hours of operation and for inspection services provided on Federal holidays regardless of the overtime status (i.e., regular time or overtime) of the inspectors.
    4. FSIS charges the establishment and provides overtime inspection coverage during the entire time that the establishment conducts activities that require overtime inspection coverage outside of the approved hours of operation (as set out in Section IV below). FSIS may pro-rate these charges when multiple establishments are operating.
    5. IPP are to be aware that the regulations require meat and poultry establishments to make requests for inspection service outside an approved work schedule as early in the day as possible for overtime work to be performed within that same workday; or before the end of the day's operation when such a request will result in overtime service at the start of the following day (9 CFR 307.4(d)(3) for meat and 9 CFR 381.37(d)(3) for poultry).  The regulations require egg products establishments to make the request with reasonable advanced notice (9 CFR 590.126).
    6. If operations or activities requiring inspection coverage occur without inspection coverage, such as outside the approved hours or outside the limits of the establishment's approved premises, FSIS may take a withholding action or suspend inspection without providing the establishment prior notification, as described in 9 CFR part 500. Products produced without inspection cannot enter commerce because they have not been inspected and found to not be adulterated and capable for use as human food as is required under 21 U.S.C. 604 and 606, 21 U.S.C. 455(b), and 21 U.S.C. 1034(a). These products may be considered adulterated because they are unfit for human food (21 U.S.C. 601(m)(3); 453(g)(3); and 1033(a)(3)). Further, if products produced without inspection bear the marks of inspection, they are misbranded under 21 U.S.C. 601(n)(1), 21 U.S.C. 453(h)(1) and 21 U.S.C. 1036.
  4. OPERATIONS OR ACTIVITIES THAT REQUIRE INSPECTION COVERAGE, INCLUDING DURING OVERTIME PERIODS
    If an establishment requests inspection service outside the approved hours of operation in accordance with 9 CFR 307.4(d)(3), 381.37(d)(3), or 590.126, IPP are to provide inspection coverage during overtime periods when an establishment:
    1. Prepares meat or poultry for packaging or for further processing into meat or poultry food products. Examples of activities that require inspection include slaughtering, boning, cutting, slicing, grinding, injecting, pumping, adding ingredients through other mechanical means, formulating, assembling, packaging, or labeling meat or poultry components of meat or poultry food products;
    2. Processes egg products. Examples of activities that require inspection include breaking eggs or filtering, mixing, blending, pasteurizing, stabilizing, cooling, freezing, drying or packaging egg products at establishments other than where noted in Section V.A.14 and 15 below;
    3. Requests the mark of inspection to be applied to any product. This applies whether the meat, poultry, or egg products are placed in a preprinted container that bears the mark of inspection or if the mark is applied after the products are placed in the container. Placing the products in a container that will bear the mark of inspection and applying the mark of inspection to products requires inspection coverage; or
    4. Marks, packages, or labels products (as required in 9 CFR 316.3(b), 381.136(a), and 590.418(b)).
  5. OPERATIONS OR ACTIVITIES THAT DO NOT REQUIRE INSPECTION COVERAGE DURING OVERTIME PERIODS
    1. IPP are not to provide overtime inspection services at establishments if the establishments will only be conducting the following types of activities during the period of operation:
      1. Monitoring a Critical Control Point (CCP) in their Hazard Analysis and Critical Control Point (HACCP) plan as required by 9 CFR 417.2(c)(4). For example, the establishment may monitor the cooking or chilling of any products with a continuous or handheld monitoring device;
      2. Conducting any form of sanitation procedure. For example, the establishment may conduct pre-operational cleaning and sanitizing of food contact surfaces required by 9 CFR 416.13(a);
      3. Monitoring the implementation of procedures included in the Sanitation Standard Operating Procedures (SOPs). For example, the establishment sanitation supervisor may monitor the implementation of the pre-operational cleaning procedures as required by 9 CFR 416.13(c);

        NOTE: When an establishment wants IPP to perform pre-op verification activities before the start of the approved hours of operation, they would need to request overtime. This includes when IPP observe the establishment monitoring the implementation of their pre-op procedures before the start of the establishment's approved hours of operation. The establishment will be charged overtime on those days that IPP perform pre-op verification activities.
      4. Moving products, including moving and handling post-lethality exposed ready-to-eat (RTE) products, within the establishment to physically position them for further processing or storage. For example, the establishment may transfer racks loaded with products from smokehouses to the cooler or remove raw tumbled products from the tumbler into tubs. For another example, the establishment may remove whole RTE hams from racks in the cooler and place them into carts, so that they can easily be moved to each slicer for slicing. Moving the hams from the racks to the carts and moving the carts out to the production floor are positioning for further processing and do not require inspection coverage when no other process is done;
      5. Receiving meat, poultry, spices, or other ingredients from other establishments or warehouses;
      6. Preparing or staging non-amenable ingredients for later use in an inspected meat or poultry product. For example, the establishment may chop vegetables or cook and cool rice but may not add the non-amenable ingredients to meat or poultry products without inspection coverage;
      7. Applying ice to products in a box or container;
      8. Quartering a beef carcass to facilitate loading or making a single cut for grade determination;
      9. Receiving and sorting returned products produced by the official establishment as described in 9 CFR 318.3;
      10. Performing a verification activity as required by their HACCP plan including: the calibration of process monitoring equipment required by 9 CFR 417.4(a)(2)(i); direct observation of the monitoring procedure required by 9 CFR 417.4(a)(2)(ii); and the review of records generated and maintained in accordance with 9 CFR 417.5(a)(3) required by 9 CFR 417.4(a)(2)(iii);
      11. Performing pre-shipment records review as required by 9 CFR 417.5(c);
      12. Performing corrective actions in accordance with its HACCP plan or Sanitation SOPs that do not include any of the activities listed under Section IV above. For example, the corrective action cannot include a reconditioning procedure that involves trimming, packaging, or labeling of products;
      13. Collecting or testing samples of its products;
      14. Stabilizing and desugaring egg products after the enzymatic or bacterial de-sugaring process commences; or
      15. Heat treatment of egg products provided IPP are present at the beginning (placing the products in the hot room) and end of the heat treatment process.
    2. The listing is not all inclusive. If IPP have questions regarding whether a particular activity requires inspection, they are to first discuss the type of activity with their Frontline Supervisor (FLS) to determine whether the establishment is preparing, packaging or labeling products. If the FLS is unable to make the determination, IPP are to submit a question through askFSIS or contact the Policy Development Staff at 1-800-233-3935.
    3. The FLS may periodically direct IPP to verify monitoring of a CCP that occurs outside of an establishment's approved hours of operation through direct observation. FSIS will charge the establishment for the cost of the overtime service outside of the establishment's approved hours of operation. If the activity occurs at a time that is not contiguous with the inspector's tour of duty, IPP are to charge the establishment for a 2-hour call-back service as set out in 9 CFR 307.6(b). The decision will be based upon a conversation with IPP, and take into consideration the following:
      1. What is the degree of variability associated with the monitoring of the CCP? In other words, is a probe inserted at the same location for every oven or is an organic acid applied at a specific strength in a specific pattern at a certain pressure? If the monitoring of the CCP is consistent and uniform, the decision may be to direct IPP to verify monitoring less often during overtime coverage than if the CCP monitoring procedure is variable;
      2. Do IPP have the opportunity to verify the specific CCP and regulatory requirements during the approved hours of operation? For example, if the establishment always monitors a certain CCP outside the approved hours of operation, IPP would verify the monitoring of the CCP during overtime periods at some frequency. However, if IPP have the opportunity to verify the CCP during the approved hours of operations, there would be less need to verify it during overtime periods; and
      3. What is the history of deviation from critical limits or noncompliance for the CCP? For example, if there has not been a deviation from a critical limit, the decision may be to verify at a reduced frequency.
    4. Similarly, the FLS may occasionally direct IPP to verify how the establishment conducts operational Sanitation SOPs outside of an establishment's approved hours of operation through direct observation. For example, an establishment may conduct Sanitation SOP procedures during the transfer of marinated products to coolers to prevent contamination and adulteration. If needed, the FLS is to determine the frequency based upon the associated risk with the specific Sanitation SOP procedure, opportunity to verify the procedure during the approved hours of operations, and the rate of Sanitation SOP noncompliance.
  6. PROVIDING INSPECTION COVERAGE FOR ESTABLISHMENTS WORKING DURING REIMBURSABLE OVERTIME PERIODS
    1. The DM, or designee, is to assign IPP to perform reimbursable overtime service in accordance with the Labor Management Agreement and work assignment policies.
    2. IPP working overtime are to calculate the time charged, including time traveled between establishments on an equitable basis among the individual establishments. If IPP have questions about how to charge for reimbursable services, they are to direct those questions to their supervisor.
      1. Supervisors are to instruct IPP to charge a quarter hour minimum charge for reimbursable overtime services and to charge additional reimbursable time in quarter hour increments;
      2. Supervisors are to instruct IPP to charge a 2-hour minimum charge for reimbursable services during overtime callback situations. A callback occurs when an establishment requests that IPP work during overtime periods that require IPP to return to or travel to the establishment after they have completed their tour of duty, have traveled home, and the supervisor has instructed the inspector to return for the callback coverage; and
      3. Supervisors are to instruct IPP when travel time associated with an overtime coverage assignment is reimbursable.
    3. The DM, or designee, is to make a reasonable effort to provide all requested reimbursable overtime services; however, the DM or their designee may deny overtime inspection services beyond the approved hours of operations when resources are not available. In some cases, to ensure the efficient and effective use of IPP in official establishments as directed by 9 CFR 307.4, 381.37, and 590.124 the DM may, after giving prior notice to the establishment that explains the basis for the action, rescind approval where the hours of operation for establishments in an assignment result in frequent non-reimbursable overtime and request that establishments resubmit operating schedules for approval.
    4. The DM, or designee, may suspend reimbursable overtime or holiday services if the establishment becomes delinquent on reimbursing FSIS for charges previously accrued as set out in 9 CFR 307.6(c), 9 CFR 381.39(c) and 9 CFR 590.130. The DM may still assign inspection services within the approved hours of operation.
  7. IPP RESPONSIBILITIES
    1. IPP are to follow the instructions set out in FSIS Directive 5010.1, Food Safety Related Topics for Discussion During Weekly Meetings with Establishment Management, to discuss topics at the weekly meeting with establishment management that are pertinent to an establishment's food safety system, which may include procedures for requesting inspection service outside the approved hours of operation or changes to the official premises.
    2. IPP are to be aware of any procedures in place for the establishment to submit requests for overtime and for the establishment to ensure FSIS has approved overtime requests before proceeding with operations outside the approved hours of operation. IPP are to:
      1. Document any agreed upon procedures for requesting inspection services outside the approved hours of operation in a memorandum of interview (MOI) in the Public Health Information System (PHIS) and include "Overtime Request Procedures" as the MOI Subject.
      2. Review the most recent MOI with "Overtime Request Procedures" as the Subject in PHIS, upon entering a new assignment, to become familiar with the establishment's procedures for requesting inspection services outside the approved hours of operation. If IPP have questions about the procedures, IPP are to discuss them with the establishment at the next weekly meeting or contact their FLS.
      3. Document a new MOI in PHIS and include "Overtime Request Procedures" as the Subject when the establishment notifies IPP of any changes to the procedures for requesting inspection services outside the approved hours of operation.
    3. If IPP determine that operations or activities requiring inspection have occurred outside the approved hours without requesting inspection services in an official establishment, IPP are to:
      1. Retain the products under 9 CFR 500.2(a)(2) if the products are still at the establishment;
      2. Immediately contact the District Office (DO) through supervisory channels to advise them about the situation, including whether adulterated or misbranded meat, poultry, or egg products may have entered commerce; and
      3. Meet with establishment management to discuss the issue and inform the establishment that the DO will be notified and will determine if further action is warranted. IPP are to document the conversation and other pertinent facts in an MOI, cite regulations 9 CFR 307.4(a), 381.37(a), or 590.24 as appropriate, and provide a copy of the MOI to the establishment and the DO.
    4. When instructed by the DO, IPP are to:
      1. Verify that any marks of inspection are removed completely from products produced outside of approved hours without inspection coverage. For product produced outside the approved hours without inspection coverage which are not labeled with the marks of inspection, IPP are to verify that the product does not receive the marks of inspection; and
      2. Verify that any product produced or prepared without inspection coverage is diverted to inedible material and disposed of appropriately, including denaturing for rendering or disposal at a landfill, denaturing and marking as not for human food, as required by 9 CFR 325.11, 381.193, or 590.840, or transport from the official establishment without denaturing under a permit required by 9 CFR 325.11(e)(1)-(5)
      NOTE: Products requiring inspection that are produced or prepared without inspection coverage are not eligible for donation into human food channels.
    5. If IPP become aware through observations, a third-party complaint, or other means, that non-official establishments are producing amenable products for commerce without inspection or that an official establishment is producing amenable products for commerce outside the limits of its official premises, they are to immediately inform their FLS of this fact.
  8. FLS RESPONSIBILITIES
    1. The FLS is to ensure that IPP document findings in an MOI and follow the DM's instructions to take action, as appropriate.
    2. If the FLS is advised by IPP that non-official establishments are producing amenable products for commerce without inspection or that an official establishment is producing amenable products for commerce outside the limits of its approved premises without inspection, including businesses that do not meet the requirements for an exemption from inspection as per 9 CFR 303.1, 381.10, or 590.100, they are to notify the DO.
  9. DM RESPONSIBILITIES
    1. The DM, or designee, is to consider whether the production of products without inspection coverage warrants an enforcement action against the official establishment, as described in 9 CFR part 500. If the DM, or designee, determines an enforcement action is warranted based on 9 CFR part 500, they are to follow the instructions in FSIS Directive 5000.1, Verifying an Establishments Food Safety System, and FSIS Directive 5100.3, Administrative Enforcement Action Decision-Making and Methodology.
    2. If the DM, or designee, determines an enforcement action against the official establishment is not warranted, they are to provide an official correspondence letter to the establishment, as described in FSIS Directive 5100.3, regarding the serious nature of producing products without inspection.
    3. The DM, or designee is to contact the appropriate Office of Investigation, Enforcement and Audit (OIEA), Regional Director (RD), or designee, in a timely manner when they become aware that an establishment is producing amenable products for commerce outside the limits of its official premises without inspection. The DM, or designee, is to coordinate with OIEA for any investigative or enforcement support, if necessary.
      1. The DM or designee may take an enforcement action against the establishment, up to a withholding action or impose a suspension without providing prior notification, when products are produced outside the official premises without inspection coverage. If the DM, or designee, determines an enforcement action is warranted based on 9 CFR part 500, they are to follow the instructions in FSIS Directive 5000.1 and FSIS Directive 5100.3.
      2. If the DM, or designee, determines the production of amenable products for commerce without inspection is occurring at a non-official establishment with no involvement of persons associated with the official establishment, they are to contact the appropriate OIEA RD, or designee, in a timely manner to coordinate additional actions as necessary, as described in FSIS Directive 8080.1, Managing Adulterated or Misbranded Meat, Poultry, and Egg Products, or FSIS Directive 8410.1, Detention and Seizure.
    4. The DM, or designee, is also to follow the instructions in FSIS Directive 8080.1, FSIS Directive 8410.1, or FSIS Directive 8010.5, Case Referral and Disposition, as appropriate, for product intended for distribution in commerce or that has entered commerce. This may include contacting the appropriate OIEA RD or coordinating actions with other program areas as necessary.
  10. QUESTIONS
    1. IPP are to first seek guidance from their immediate supervisor for any questions associated with overtime schedules or supervisory decisions that require overtime inspection. IPP are to refer establishment appeals of overtime charges to their supervisor.
    2. Refer questions regarding this directive to your supervisor or, if needed, to the Office of Policy and Program Development through askFSIS or by telephone at 1-800-233-3935. When submitting a question, complete the web form and select General Inspection Policy inquiry type.

      NOTE: Refer to FSIS Directive 5620.1, Using askFSIS, for additional information on submitting questions.