1. PURPOSE
   This directive sets out the procedures inspection program personnel (IPP) are to follow when examining the condition of canned product containers that are domestically produced.  This directive does not apply to reinspection of imported canned products, which is provided in FSIS Directive 9900.2, Import Reinspection of Meat, Poultry, and Egg Products.  FSIS has rewritten this directive in its entirety to clarify the current procedures for condition of container examinations (COCE) for canned products.  FSIS has updated the glossary for container defects and FSIS Form 7520-1, Condition of Container Examination Score Sheet.  This directive also describes how to use the COCE tool for sample selection and lot disposition with updated examples in the attachment.
   
   KEY POINTS:
   • Updates regulatory citations with the consolidated canning regulations (9 CFR 431) published on05/31/2018 (83 FR 25302)
   • Changes the frequency of condition of canned product container examinations from routine to an ad hoc basis
   • Clarifies the purpose of COCE procedure
   • Streamlines the COCE procedure with the use of the COCE tool in FSIS Applications
   • Updates container defect glossary and FSIS Form 7520-1
2. CANCELLATION
   FSIS Directive 7520.2, Procedures for Condition of Canned Product Container Examination, 5/12/88
3. BACKGROUND
   Thermally processed, commercially sterile (canned) products are required to be packed in hermetically sealed containers, which protect the contents against the entry of microorganisms during and after thermal processing.  Abnormal containers may be caused by different reasons, such as under-processing, leakage, chemical reaction, or elevated storage temperature.  Although some hermetically sealed containers (e.g., pouches and glass) used to package canned products are not technically "cans," the term ‘‘canned product,’’ as defined in 9 CFR 431.1, describes all thermally processed, commercially sterile products regardless of actual packaging material.  The COCE is intended to determine whether the canned product containers have any critical or major defects that may be indicators of under-processing of product, or whether the defects may substantially affect the integrity and hermetic seal of the containers.
4. CONDITION OF CONTAINER EXAMINATION - STATIONARY LOT SAMPLING
   1. IPP are to verify that only normal-appearing containers are shipped from an establishment (9 CFR 431.10 (c)(1)).  During daily inspection, IPP are to stay alert concerning any evidence of container damage or abnormal containers in stationary lots (lots warehoused or ready for shipment).  Wet or stained cases, damaged cases, odor, leaking containers, and swollen containers in the establishment’s storage areas may indicate problems with the hermetic condition of the sealed containers or potential process deviation.  When IPP encounter production lots with abnormal containers, they are to follow the instructions in FSIS Directive 7530.1, Handling a Process Deviation or Abnormal Container of Thermally Processed, Commercially Sterile Canned Product, and retain the affected lot if the establishment does not have control of the affected lot.
      
      NOTE:  When there is obvious forklift or transportation damage, IPP are to permit removal of the damaged containers without retaining the lot provided that the damage is not a prevailing condition throughout the lot.
   2. The COCE helps IPP to evaluate the overall condition of the lot and determine whether the establishment has met the requirement in 9 CFR 431.10(c).  IPP are to initiate the COCE only when there is reason to suspect the integrity of the containers in a lot or as directed by their immediate supervisor, Frontline Supervisor (FLS) or District Office (DO) on an ad hoc basis.  For example, IPP may initiate a COCE when the establishment’s finished product inspection procedure (9 CFR 431.10(a)) is not conducted properly or when abnormal containers are observed in the lot.  IPP may also initiate the COCE to evaluate a sorted, reconditioned or returned lot of product after the establishment has performed its corrective action in an abnormal container incident.
   3. If IPP decide to conduct the COCE, they are to initiate a directed Thermally Processed, Commercially Sterile HACCP Task in the Public Health Information System (PHIS).  IPP are to verify whether the establishment has met the regulatory requirement in 9 CFR 431.10(c)(1) and document the results in the HACCP task in PHIS.  
   4. If the establishment has an incubation program, IPP are to perform the COCE after the incubation period has elapsed.  This will allow for potential microbial action and the resulting abnormal containers can be detected during the COCE.
5. SAMPLING PLAN
   1. IPP are to complete Section A of FSIS Form 7520-1 , Condition of Container Examination Score Sheet   (available at InsideFSIS; users need an e-authentication account to access this form).
   2. Table 1 shows the number of sample units (immediate containers) to select based on the lot size and sampling plan, i.e., normal vs. tightened.
      1. IPP are to use the normal sampling plan for initial COCE for any specific lot. 
      2. IPP are to use the tightened sampling plan for a lot that failed previous COCE or when directed.  For a failed lot, IPP are to re-examine the lot at the request of the establishment only when there is evidence that the lot has been reconditioned or sorted by the establishment.
6. SAMPLE SELECTION
   1. IPP are to virtually designate numbers for each pallet and designate numbers for each case on the pallets using a predetermined pattern (see Example 1 in Attachment 2);
   2. IPP are to use the COCE tool (Available at "FSIS Applications - Tools") for sample selection. 
   3. IPP are to enter the lot information at the COCE tool "Input" section and click "Calculate".  The COCE tool will generate sampling information, such as the number of boxes to select, the number of immediate containers to select from each box and the locations of each box in the lot.
      
      NOTE:  Two examples are provided in Attachment 2 to help IPP understand the sampling procedure using the COCE tool.
   4. IPP are to draw samples from the lot according to the sampling information generated by the COCE tool.
7. EXAMINATION, CLASSIFICATION AND RECORDING OF CONTAINER DEFECTS
   1. IPP are to examine each sample unit visually and manually for the defects described in Section B of FSIS Form 7520-1.
      
      NOTE:  A glossary of the terms used on FSIS Form 7520-1 is provided in Attachment 1 to help IPP identify different types of container defects.  Additional guidance on classification of container defects can be found in IPP Help - Condition of Containers Examination.
   2. IPP are to remove the label when there is evidence of stains or damage or when container overwraps obscure visual examination.
   3. IPP are to record all results on FSIS Form 7520-1 with the following rules in mind:
      1. If two or more defects are found on the same sample unit and indicate the same cause, the defects are considered related and scored once.  For example, if two locations are corroded, IPP are to score only once;
      2. If more than one related defect is found and one is critical and the other is major, IPP are to score once as critical;
      3. If the defects on the sample unit indicate different causes, IPP are to consider the defects unrelated and score as separate defects.  For example, if a can is dented and has a sharp seam, IPP are to score two defects; and
      4. Product containers with defects that are not part of the sample are to be removed and handled per Section VIII below.  IPP are not to score these defects as part of the sample result. 
   4. If IPP notice a recurrence of scorable or unscorable defects, they may note this in the Remarks box of the FSIS Form 7520-1 as a reminder to conduct further investigations.
      
      NOTE:  An unscorable defect is a defect often referred to as a minor defect.  A minor or unscorable defect has no adverse effect on container integrity.
8. DISPOSITION OF DEFECTIVE SAMPLE UNITS
   1. If abnormal containers (9 CFR 431.1) are found during the COCE and the containers exhibit no obvious mechanical defect, IPP are to retain the lot because this finding may indicate a potential process deviation or product adulteration. 
   2. IPP are not to allow abnormal containers with no obvious mechanical damage to be destroyed before completing the verification of establishment’s handling of the abnormal container incident according to the instructions in FSIS Directive 7530.1.
   3. IPP are to verify that the establishment destroyed containers with critical defects.
   4. IPP are to be aware that whenever any major defects are found in the sample, the establishment may decide on the disposition of these containers provided that the establishment ensures that only normal appearing containers are shipped in commerce (9 CFR 431.10(c)(1)).
9. DISPOSITION OF AFFECTED LOTS AND DOCUMENTATION
   1. IPP are to use Table 2 below to determine whether the overall condition of the lot is acceptable. 
   2. IPP are to follow the instructions in FSIS Directive 7530.1 to verify that the establishment handles the abnormal container incident appropriately in accordance with 9 CFR 431.10(a) even if the lot has passed the COCE according to Table 2.
   3. IPP are to issue a noncompliance record (NR) citing 9 CFR 431.10 (c)(1) if the establishment fails the COCE.  IPP are to document the COCE results in the description of the NR in a Thermally Processed, Commercially Sterile HACCP task in PHIS. 
   4. IPP are to verify that the disposition proposal from the establishment includes disposition of all defective containers in accordance with 9 CFR 431.10(c)(2). 
   5. If IPP need assistance in evaluating the supporting data and disposition of affected product, IPP are to forward the disposition proposal and supporting document to the Policy Development Staff (PDS) through askFSIS.  When submitting a question, IPP are to complete the web form and select General Inspection Policy for the inquiry type. 
   6. IPP are to include their FLS’s contact information in the askFSIS case submission. 
   7. The Policy Development Staff (PDS) is to review the proposal and supporting documents and issue a disposition recommendation to the DO through the FLS.
   8. The DO is to review the disposition recommendation from PDS, make the final ruling on the disposition of the affected product, and notify the IPP through the chain of command.
10. QUESTIONS

Refer questions regarding this directive to your supervisor or as 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 for the inquiry type. 
NOTE:  Refer to FSIS Directive 5620.1, Using askFSIS, for additional information on submitting questions.

(For completed FSIS Directive 7520.2 Revision 1, please download the PDF version)