
Talmadge-Aiken Cooperative Inspection
FSIS directive
5720.4
Series Type
5000 Series: Program Services
Issue Date
Dec 17, 2024
Full Directive
CHAPTER I - GENERAL
- PURPOSE
This directive provides the instructions that FSIS personnel are to follow when establishing, continuously overseeing, or ending Talmadge-Aiken Cooperative Inspection Agreements (hereafter "TA cooperative agreements") under the Federal-State Cooperative Inspection Program. - CANCELLATION
FSIS Directive 5720.2, State Cooperative Inspection Programs, 11/16/04 - BACKGROUND
- The Talmadge-Aiken Act (7 U.S.C. 1633) authorizes FSIS to enter into a cooperative agreement with a State Department of Agriculture, or any other State agency responsible for its meat or poultry inspection (MPI) program, to assist in the administration and enforcement of the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 et seq.), Poultry Products Inspection Act (PPIA) (21 U.S.C. 451 et seq.), and accompanying regulations, whenever it is feasible and in the public interest to avoid duplication of functions, facilities, and personnel.
- Under this authority, FSIS has historically entered into two types of agreements: TA and Cross-Utilization (CU) cooperative agreements. The agreements served the same purpose and have the same inspection and oversight requirements. To simplify and streamline paperwork for state cooperative agreements, FSIS will no longer use CU cooperative agreements. Going forward, all state cooperative agreements under the Talmadge-Aiken Act will be TA cooperative agreements.
- Under TA cooperative agreements, State inspectors working in TA establishments under Federal inspection are performing their inspection duties on behalf of FSIS. Therefore, these State inspectors are to meet the same inspection training and duty requirements as Federal inspectors. They are to follow FSIS Directives and Notices. In addition, they are to use FSIS information technology applications and properly document their inspection findings in the Public Health Information System (PHIS). Any appeals of State inspectors' decisions at Federal establishments are to be sent to the appropriate official in the FSIS chain of command, starting with the assigned FSIS Frontline Supervisor (FLS) (see 9 CFR 306.5).
CHAPTER II - TA AGREEMENT COORDINATORS
- The Assistant Administrator (AA), Office of Field Operations (OFO), is to designate an FSIS Headquarters (HQ) TA Agreement Coordinator to serve as the primary OFO HQ contact for TA cooperative agreements. The HQ TA Agreement Coordinator is responsible for preparing and seeking approval for TA cooperative agreements, maintaining copies of TA cooperative agreements, and preparing reports related to TA cooperative agreements for review by senior management and public posting on FSIS' website.
- In Districts with a TA cooperative agreement in place, FSIS District Managers (DMs) are to designate a District Office (DO) TA Agreement Coordinator to work with the HQ TA Agreement Coordinator. The DO TA Agreement Coordinator is the primary DO contact for TA cooperative agreements and is responsible for preparing annual reports for the HQ TA Agreement Coordinator (see Chapter IV).
CHAPTER III - ENTERING INTO A NEW TA COOPERATIVE AGREEMENT WITH A STATE
- If an FSIS District Manager (DM), determines that using State inspectors for Federal inspection would be feasible and in the public interest to avoid duplication of functions, facilities, and personnel, the FSIS DM is to make contact with the respective State for concurrence and make a recommendation to the appropriate Executive Associate for Regulatory Operations (EARO), HQ TA Agreement Coordinator, OFO Deputy AAs (DAAs), and the OFO AA that FSIS enter into a new TA cooperative agreement with a State. If the OFO AA agrees, the HQ TA Agreement Coordinator, in consultation with the FSIS Office of the Chief Financial Officer (OCFO), is to prepare a memo for the FSIS Administrator recommending that FSIS enter into a new TA cooperative agreement.
- If the FSIS Administrator approves the TA cooperative agreement, the Administrator or designee and an appropriate State Agriculture official will sign the TA cooperative agreement prepared by the HQ TA Agreement Coordinator.
- After the agreement is signed, the FSIS DM or designee is to:
- Assign an FSIS FLS to the TA establishment and ensure that the FLS is entered into the PHIS establishment profile for the TA establishment and that "Talmadge-Aiken" is selected under the "Facility, Jurisdiction" tab. Ensure that the State understands that State inspectors are to follow the instruction of the assigned FSIS FLS.
- Ensure that the State understands that TA establishments are Federal official establishments and, therefore, State inspectors are to enforce all requirements of the FMIA and PPIA.
- Ensure that the State understands that State inspectors will also need to enforce the Humane Methods of Slaughter Act of 1978 (HMSA) (7 U.S.C. 1901 et seq.) in TA establishments that slaughter livestock.
- Ensure that the State understands that State inspectors are to follow all of FSIS' Directives and Notices and properly document all inspection activities and findings in PHIS, including tasks, Memoranda of Interview (MOIs) and Noncompliance Records (NRs). Ensure that the State understands that State inspectors are to maintain the establishment profile in PHIS and answer PHIS questionnaires, when distributed;
- Ensure that when FSIS' Directives and Notices instruct inspectors to notify their supervisors, the State understands that state inspectors are to notify their assigned FSIS FLS along with their State immediate supervisor.
NOTE: The inspection standard for TA establishments is different than the inspection standard that particular States may use to operate their own MPI programs. Because in TA establishments State inspectors are inspecting on behalf of FSIS, they are to adhere to the same inspection standards as Federal inspectors. By contrast, State inspectors who are inspecting as part of the State MPI programs adhere to the state inspection standards that do not need to be the "same as" FSIS' inspection program. State MPI programs must meet and enforce requirements "at least equal to" those imposed under the FMIA, PPIA, and HMSA. - Ensure that the State understands that FSIS approves qualified State inspectors. In order for a State inspector to be qualified, they are to complete all required FSIS inspection training. The State is to demonstrate to the DM that State inspectors are trained and qualified to perform their duties before they begin inspecting on behalf of FSIS. The DM is to instruct the assigned FSIS FLS to verify that State inspectors have received, and passed, all Federal inspection training by emailing FSISAgLearn@usda.gov to request training history. The FSIS FLS is to include the employees' full names and associated District Office. If the DM finds that a State inspector is not fully trained, the DM or designee is to notify the State that FSIS is revoking approval of that State inspector.
- Ensure that the State understands that they are to enter and maintain staffing assignment information in PHIS. FSIS will assess the staffing assignment information during its annual review (see Chapter IV).
- Ensure that the State understands that inspection records are Federal records. They are subject to the Federal recordkeeping requirements outlined in the Federal Records Act (44 U.S.C. Chapters 21, 29, 31, and 33), as amended, and FSIS Directive 2620.1, FSIS Records Management Program.
- Ensure that the State understands that FSIS will review establishments inspected under TA cooperative agreements using the same management controls that it uses for other Federal establishments to monitor performance. Explain that FSIS DOs will routinely run inspection reports using PHIS data to monitor performance (e.g., task completion rate) and track trends (see Chapter IV).
- Provide the State with all necessary FSIS forms, tags, seals, export stamps, and certificates.
- Refer the State to FSIS' State Program Resources, which provides information for State inspectors regarding all necessary inspection training, and obtain FSIS LincPasses and FSIS equipment (if needed).
- Coordinate with the State to select establishments to be inspected under the agreement.
CHAPTER IV - FEDERAL OVERSIGHT OF TA COOPERATIVE AGREEMENTS
- GENERAL
- As instructed in more detail below, FSIS personnel are to provide continuous oversight of TA establishments by:
- Conducting an annual review of all TA agreements and establishments;
- Performing annual onsite reviews that include reviews of inspection training and inspection records and observations of inspection activities;
- Reviewing PHIS reports quarterly to look for trends and inspection issues;
- Maintaining communication with State inspectors and conducting additional onsite visits when needed;
- Performing Public Health Risk Evaluations (PHREs) or Food Safety Assessments (FSAs); and
- Conducting routine financial reviews of reimbursements.
- This section provides instructions on how to conduct federal oversight of TA cooperative agreements and what FSIS personnel are to do if they identify noncompliance during their oversight activities (e.g., have additional discussions with State inspectors, direct State inspectors to do additional sampling, take appropriate regulatory control or enforcement action, or request an FSA).
- As instructed in more detail below, FSIS personnel are to provide continuous oversight of TA establishments by:
- ONSITE REVIEW
- At least annually, the FSIS FLS, or designee, is to conduct an onsite review in each TA establishment in the State to verify that it is operating in compliance with the FMIA, PPIA, HMSA, and FSIS' implementing regulations (9 CFR Chapter III). When possible, the FSIS FLS or designee is to coordinate with the State to schedule onsite reviews so the State supervisor(s) may accompany the FSIS FLS or designee on the onsite review. However, if the State supervisor(s) are unavailable or FSIS has reason to suspect a time-sensitive food safety issue, the FSIS FLS or designee is to conduct unannounced and unaccompanied reviews.
- During the onsite review, the FSIS FLS, or designee, is to verify that the TA establishment is receiving the necessary inspection services from State inspectors. The FSIS FLS or designee is to perform onsite verification visits on days when State inspectors are conducting inspection activities for federally inspected products in the TA establishment. The FSIS FLS or designee is to:
- Complete FSIS Form 5720-3, State On-site Review Checklist, and mark "In-depth Issuance Review" as N/A for TA establishments because all issuances used are FSIS issuances and the reference for "at least equal to" does not apply when reviewing TA establishments. The FSIS FLS or designee is to include a written overview description to summarize the verification activities, findings, and assessment of whether of the TA establishment reflects all applicable Federal requirements. This written overview description will also serve as the confirmation that all onsite verification activities, as instructed in this directive, were completed; and
- Verify that all State inspectors in the TA establishment have received and completed mandatory Federal inspection training. To prepare for the onsite review, the FSIS FLS is to email FSISAgLearn@usda.gov to request a report on the State inspectors' training in AgLearn. If any inspectors have not received all Federal inspection training, the FSIS FLS or designee is to notify the DM.
- Verify that State inspectors are providing inspection services to establishments in compliance with FSIS Directives and Notices. Before the onsite review, the FSIS FLS or designee is to review State inspectors' NRs, MOIs, weekly meeting notes, enforcement records associated with the establishment's food safety systems, and laboratory sampling results. This records review, along with any direct observation of State personnel performing inspection during the onsite review, is to be used by the FSIS FLS or designee to verify that:
- State inspectors apply appropriate Federal inspection methodology;
- State inspectors use effective decision making to determine whether there is noncompliance with Federal requirements;
- State inspectors appropriately document findings and, when necessary, initiate appropriate enforcement actions authorized under the FSIS Rules of Practice in 9 CFR part 500;
- State inspectors collect product samples according to instructions in FSIS Directives and Notices; and
- State inspector staffing levels for each of the establishments are appropriate to carry out the required inspection activities in the same manner as Federal inspection. The FSIS FLS or designee is to compare the establishment's hours of operation to the inspection records to determine whether an establishment received the necessary inspection services whenever the Federal mark of inspection was applied.
- Assess each establishment's compliance with the FMIA, PPIA, HMSA, and FSIS' implementing regulations (9 CFR Chapter III) as applicable. The FSIS FLS or designee is to:
- Review the written sanitation SOP and a sample of establishment daily records documenting the implementation of the sanitation SOP and any corrective actions taken;
- Observe the condition of the establishment's grounds and facilities, equipment and utensils, employee hygiene, and sanitary operations to determine whether the establishment complies with sanitation performance standards in 9 CFR 416.1 through 416.6;
- Observe the establishment employees perform their duties;
- Review the establishment's Hazard Analysis and Critical Control Point (HACCP) system and associated records (e.g., hazard analyses, HACCP plans, prerequisite programs, critical control points (CCP), critical limits, monitoring and verification procedures and frequencies, corrective actions, and supporting documentation);
- Verify that any new technology (including new ingredients and antimicrobials), on-line reprocessing or off-line reprocessing systems, regulatory waiver requests, or protocols requesting to conduct an in-plant trial implemented by a Federal establishment under a TA cooperative agreement have been reviewed by the Office of Policy and Program Development (OPPD) Risk Management and Innovations Staff as outlined in FSIS Directive 5020.2, The Technical Review Process;
- Review other food safety, economic and non-food safety specific processes that require regulatory oversight, such as labeling, product formulations, and use of safe and suitable ingredients, as explained in FSIS Directive 7120.1, Safe and Suitable Ingredients Used in the Production of Meat, Poultry, and Egg Products;
- Review the establishment's compliance with all applicable Federal regulatory requirements (e.g., condemned product handling, humane handling, and removal, segregation, and disposition of specified risk materials); and
- Instruct the State inspector to collect and submit product samples for analysis, if needed, to verify that the product produced by the establishment meets Federal requirements.
- Initiate appropriate enforcement action if the FSIS FLS or designee determines that an establishment is not operating in compliance with the FMIA, PPIA, HMSA, or FSIS' implementing regulations (9 CFR Chapter III).
- Initiate any appropriate enforcement action provided for in the FSIS Rules of Practice under 9 CFR part 500 if the FSIS FLS or designee determines that an establishment is operating in a manner that is inconsistent with the FMIA, PPIA, HMSA, or FSIS' implementing regulations (9 CFR Chapter III), in accordance with FSIS Directive 5100.3, Administrative Enforcement Action Decision-Making and Methodology.
- Consult with the DM to determine whether to request that an FSIS Enforcement, Investigation, and Analysis Officer (EIAO) conduct an FSA or that an FSIS veterinarian assess humane handling and slaughter at the establishment.
- After the FSIS DM reviews FSIS Form 5720-3, the FSIS FLS or designee is to provide an electronic copy of the form to the State. The FSIS FLS or designee is to include the following information on the form.
- Establishment number, name of the establishment, and physical address;
- Date of onsite visit;
- FSIS and State inspection personnel present;
- Operations on the day of the visit and specify which were directly observed by FSIS;
- Whether the establishment was producing products under Federal inspection at the time of the verification visit;
- The inspection activities the FSIS FLS or designee directly observed the State inspector performing during the visit and if the FLS or designee observed any potential problems or regulatory noncompliance; and
- Whether regulatory compliance or noncompliance with all applicable Federal standards was observed:
- If regulatory noncompliance was observed, the FSIS FLS or designee is to identify the type of regulatory noncompliance, the State inspector's response, and outcome (e.g., "HACCP recordkeeping noncompliance was observed for raw intact CCP monitoring and documented by the State inspector in an NR; no additional regulatory actions required");
- When regulatory compliance is observed, the FSIS FLS or designee is to identify the same types of applicable information as when noncompliance is observed. For example, "During the onsite visit, the establishment produced raw intact beef products. I directly observed the State inspector perform Sanitation Performance Standards (SPS), Sanitation Standard Operating Procedures (SOP), HACCP, and labeling verification of raw intact operations. I reviewed the establishment's written programs for these processes and directly observed that the appropriate inspection methodology was applied and concurred with the State inspector's assessment of the establishment's regulatory compliance with applicable Federal requirements;" and
- Ensure that necessary inspection documentation has been reviewed (e.g., PHIS Reports, NRs, MOIs, Laboratory Sampling Result Records). The FSIS FLS or designee is to specifically identify the name and date period of each report and documentation type reviewed before and during the onsite review. For example, "Before the onsite review, I reviewed the PHIS Reports Establishment Data Summary, Establishment Profile, MOIs for an Establishment, Noncompliance Records for an Establishment, and Task Summary for an Establishment for 1/1/2019 - 4/15/2019." The FSIS FLS or designee is to review electronic versions of the documentation in advance of the onsite visit, and review hard copy records onsite, as needed. If the FSIS FLS or designee identifies any issues with the documentation, they are to note the issues on the form and discuss the issues with the State inspector.
- ANNUAL REVIEW AND REPORT
- TA cooperative agreements are subject to annual review and are contingent on the State's demonstrated ability to enforce all Federal requirements and implement all FSIS inspection tasks and procedures, and the agreements remaining feasible and in the public interest to avoid duplication of functions, facilities, and personnel. Annually, the HQ TA Agreement Coordinator is to prepare a report for the FSIS Administrator recommending whether the Agency should extend or end existing TA cooperative agreements.
- During the annual review, the HQ TA Agreement Coordinator is to provide FSIS OCFO with an assessment of the staffing for each TA plant, including the position type, grade level, and estimated number of work hours needed per employee per year.
- FSIS OCFO is to review the spending details for all TA establishments and prepare a cost analysis that compares costs for State staffing, management, travel, and overhead to costs for FSIS staffing, management, travel, and overhead costs. FSIS OCFO is to provide the cost analysis to the HQ TA Agreement Coordinator to inform the HQ TA Agreement Coordinator's recommendations and the analysis should be included in the annual report to the FSIS Administrator.
- Additionally, to inform HQ TA Agreement Coordinator's recommendations, each DO TA Agreement Coordinator is to prepare an annual report for the HQ TA Agreement Coordinator. For the purpose of this submission, the DO TA Agreement Coordinator is to verify the accuracy of the report, resolve any errors with FSIS FLSs and the DM, and distribute the finalized report to the HQ TA Agreement Coordinator for submission to the OFO AA. The annual report is to include:
- An assessment of whether the activities of State inspectors in TA establishments comply with FSIS Directives and Notices;
- A list of all TA establishments and date of last review.
- A copy of each FSIS Form 5720-3 completed that year;
- A list of any establishments that were added or removed during the year and the reason why they were added or removed; and
- A recommendation to extend or end the TA cooperative agreements with a brief justification of why it is in the public interest for each establishment receiving TA inspection to continue to receive federal inspection under the TA agreement, rather than inspection directly by FSIS. The DO is to explain whether the TA cooperative agreements are necessary to avoid duplication of functions, facilities, and personnel.
- The FSIS Administrator is to consider the annual report when determining if the Agency will extend the TA cooperative agreements, or take another action in accordance with Chapter V.
- After the FSIS Administrator reviews the report, the HQ TA Agreement Coordinator is to post the report on the FSIS website.
- ADDITIONAL FEDERAL OVERSIGHT
- The DM or designee is to continuously oversee establishment performance by reviewing management control reports in PHIS for TA establishments at least once per quarter. If the DM or designee identifies discrepancies (e.g., task completion targets have not been met), the DM or designee is to discuss the issues with the assigned FSIS FLS. If needed, the FSIS FLS is to follow up with the appropriate State inspector. The DM or designee is also to consider the management control reports when deciding whether to assign Federal inspectors to inspect an establishment previously staffed by State inspectors under a TA cooperative agreement.
- In addition to the annual onsite review, the FSIS FLS is to have ongoing communication with State inspectors and conduct onsite visits, as needed. During these onsite visits, the FSIS FLS is to observe the State inspectors and establishment operations. However, the FSIS FLS is not expected to complete all the steps listed above in Chapter IV, I, Onsite Review. The FSIS FLS is to consider the complexity of the establishment's operations, type and amount of production, and the establishment's performance when determining if additional visits are necessary to ensure food safety.
- EIAOs are to follow FSIS Directive 5100.4, Public Health Risk Evaluation Methodology, when scheduling, conducting, and documenting PHREs at TA establishments in PHIS. The PHRE is a decision-making analysis used by an EIAO to inform DO decisions. Based on PHRE findings, an EIAO may:
- Conduct an FSA at a TA establishment as described in FSIS Directive 5100.1, Food Safety Assessment Methodology;
- Take an administrative enforcement action at a TA establishment as described in FSIS Directive 5100.3, Administrative Enforcement Action Decision-Making and Methodology; or
- Take no action because enforcement action or an FSA is not needed.
- There may be situations where establishment management notifies the State inspector that adulterated product has been shipped into commerce in accordance with 9 CFR 418.2. If the State inspector finds or is notified that adulterated product may have entered commerce, the State inspector is to follow Directive 5000.1, Verifying an Establishment's Food Safety System.
- FSIS OCFO is to conduct routine financial reviews of reimbursements made under TA cooperative agreements.
CHAPTER V - ENDING STATE COVERAGE AT SPECIFIC FEDERAL OFFICIAL ESTABLISHMENTS, CORRECTIVE ACTIONS, AND TERMINATING TA COOPERATIVE AGREEMENTS
- GENERAL
- FSIS may terminate a TA cooperative agreement for any reason. FSIS may consider terminating a TA cooperative agreement if a State fails to conduct inspection services at TA establishments in a manner that complies with the FMIA, PPIA, or HMSA, and is not consistent with FSIS Directives and Notices. FSIS may also consider terminating a TA cooperative agreement if it is no longer feasible and in the public interest to avoid duplication of functions, facilities, and personnel. Generally, FSIS will provide a State with written notice at least 14 days before terminating a TA cooperative agreement. However, FSIS may provide less notice if the Agency decides it is necessary to terminate a TA cooperative agreement to protect public health.
- FSIS may also decide the Agency no longer needs a State's assistance in providing inspection personnel at specific Federal official establishments under a TA agreement. FSIS retains the authority to assign or reassign Federal inspectors to any Federal establishment for any reason. FSIS will try to provide States with written notice at least 14 days before ending State coverage at specific Federal establishments. However, FSIS may provide less notice if the Agency decides it is necessary to end State inspection coverage to protect public health.
- A State may terminate a TA cooperative agreement for any reason. A State is to provide FSIS with written notice at least 14 days before terminating a TA cooperative agreement.
- A State may also decide to stop inspecting specific Federal establishments for any reason. A State is to provide FSIS with written notice at least 14 days before it stops inspecting specific Federal establishments.
- ENDING STATE COVERAGE AT SPECIFIC FEDERAL ESTABLISHMENTS
When the DM decides that State assistance is no longer needed at a specific federal establishment, the DM is to notify the HQ TA Agreement Coordinator, the appropriate EARO, and the OFO DAAs and AA. If the OFO AA agrees, the DM is to send written notice to the State with the date that FSIS will begin staffing the establishment. The DM is to note the change in the annual report to the HQ TA Agreement Coordinator. - CORRECTIVE ACTIONS
- If the FSIS FLS and DM identify deficiencies with a State's inspection of a TA establishment, but the appropriate EARO, OFO DAAs and AA, and FSIS Administrator determine it is in the public interest to continue State inspection under a TA cooperative agreement, the DM is to verbally notify the State and follow up the with a written notification. The written notification is to clearly specify any deficiencies and state that the State is to submit a corrective action plan within 30 days.
- The FSIS DM, is to review the State's corrective action plan to determine whether it:
- Includes corrective actions that will address all the deficiencies identified by FSIS if properly implemented;
- Ensures that meat and poultry products being produced by TA establishments in the State are safe, wholesome, not adulterated, and properly labeled and packaged;
- Includes a timeline for implementation; and
- Includes a plan to verify effective resolution of all identified deficiencies.
- The FSIS DM is to verify that the State has effectively implemented the corrective action plan within the timeframe identified in the plan.
- If the State's written corrective action plan is inadequate, or if the State fails to develop or effectively implement the corrective action plan, the FSIS FLS and the DM are to notify the OFO HQ TA Agreement Coordinator, appropriate EARO, and the OFO DAAs and AA and recommend to the FSIS Administrator that the State's TA cooperative agreement be terminated.
- TERMINATION OF A TA COOPERATIVE AGREEMENT
- If the FSIS FLS, DM, EARO, OFO DAAs and AA, and FSIS Administrator determine that State personnel are not providing inspection services in accordance with FSIS Directives and Notices, or the State's written corrective action is inadequate, or the agreement is no longer feasible and in the public interest to avoid duplication of functions, facilities, and personnel, the DM is to verbally notify the State and follow up the with a written notification of termination 14 days before terminating the TA cooperative agreement. The written notification will specify the reason for termination and state the date the TA cooperative agreement will be terminated.
- If a State requests to terminate a TA cooperative agreement, the DM is to notify the HQ TA Agreement Coordinator, the appropriate EARO, and the OFO DAAs and AA. These personnel will notify the State that it is to send written notification describing the reasons for terminating the TA cooperative agreement and stating the date the TA cooperative agreement will be terminated.
- The DM is to assign FSIS inspectors to provide inspection at each establishment where TA inspection was previously provided by state inspectors.
- Nothing in this section alters FSIS' discretion to terminate a TA cooperative agreement at any time and for any reason.
CHAPTER VI - QUESTIONS
Refer questions through supervisory channels.