Part 4, Section 7, "Incubation", dated April 1, 2002

1. Abnormal Container is a container with any sign of swelling or product leakage or any evidence that the contents of the unopened container may be spoiled. All containers with critical defects (swell, flipper, springer, loose tin, overfill, leaker, or burst container) are abnormal.

2. Hermetically Sealed Container is an airtight container which is designed and intended to protect its contents against the entry of microorganisms during and after thermal processing. Retorted pouches would fall into this category.

3. Thermally Processed-Commercially Sterile Shelf Stable Canned Product is a meat or poultry food product with a water activity above 0.85 that receives a thermal process either before or after being packed in a hermetically sealed container. For the purpose of this instruction, the term "canned" product refers to all imported products packed in hermetically sealed containers.

1. Imported Products Requiring Incubation

2. Selecting Samples

When selecting samples for incubation testing, the inspector shall

1. Randomly select 48 sample units from the lot. The first 24 samples are used as the initial sample and the second 24 samples are used as the reserve sample. All incubation samples shall be secured by the inspector, and the reserve sample shall be used only when a new incubation sample is needed for the involved lot.

2. Select only normal-appearing containers.

3. When applicable, randomly select the incubation samples from those samples selected for a condition of container examination. The incubation samples may be selected after or during the container examination.

3. Time and Temperature Requirements

   1. The incubation samples are held in the incubator for no less than 10 days or 240 hours at 95^oF + 5^oF (35^oC + 2.8^oC).

   2. When the incubator temperature drops below 90^oF (32.2^oC), the temperature shall be adjusted to within the required range and the incubation time extended for the same amount of time the samples were held at the lower temperature.

   3. When the incubator temperature exceeds 100^oF (37.8^oC) but does not reach 103^oF (39.5^oC), or equals or exceeds 103^oF (39.5^oC) for less than 2 hours, the temperature shall be adjusted to within the required range and the incubation time extended for the same amount of time the samples were held at the higher temperature.

4. When the incubator temperature equals or exceeds 103^oF (39.5^oC) for more than 2 consecutive hours, the inspector shall

1. Terminate the incubation test and remove and return the samples to the lot;

2. Require the import facility management to adjust the temperature of the incubator to within the required range; and

3. Place the reserve 24 sample units inside the incubator and restart the incubation test.

4. Incubation Procedures

   1.  For each lot that is assigned an incubation type of inspection (TOI), the inspector who starts the incubation testing procedures shall

      1. Secure the temperature recording device with a lock or seal;

      2. Record on the temperature chart the date and time the incubation period started and, if applicable, the serial number of the seal used to secure the recording device. The inspector initials the entries recorded on the chart.

      3. Establish the Incubation Log, FSIS Form 9550-1, by recording all applicable information including the temperature chart identification number.

      4. Place the initial 24 sample units inside the incubator provided by the import facility and secure the incubator with a lock or seal. If a seal is used to secure the incubator, record the serial number of the seal is recorded on the Incubation Log.

   2. The inspector assigned to the import facility shall:

      1. Check the temperature chart and verify all incubation samples daily, if practical, but at least twice during the 10-day (240 hours) period.

      2.  Record on the Incubation Log the date that the incubation samples were verified and, if applicable, the serial number of the new seal used to secure the incubator. These entries are initialed by the inspector.

      3.  When it becomes necessary to replace the temperature chart, the procedures described in D.1.b above are followed. Completed temperature charts are filed with a copy of the Incubation Log in the inspector’s office.

   3. When in use, the temperature recording device and incubator shall be secured by the inspector at all times.

5. Disposition of the Lot

   1. At the completion of the incubation testing, the inspector examines each container for abnormal defects. Abnormal defects are defined in Part 4, Section 6, Condition of Container, for each type of applicable product packaging.

   2. If no abnormal containers are found, all initial and reserve sample units are returned to the lot, and the inspector permits the lot to be stamped "U.S. Inspected and Passed" (if not already pre-stamped) and released. The inspector shall then enter the incubations results as "Accepted" in the AIIS.

   3. If an abnormal container is found, the inspector shall

      1. Immediately refrigerate all "swell" containers, if applicable, and place all remaining incubation samples (including all other abnormal containers) in a non-refrigerated area to allow them to cool down to room temperature.

      2. Secure all incubation samples.

      3. After 24 hours, reexamine all incubation samples.

         1. If no abnormal container is found, the lot is permitted to be stamped "U.S. Inspected and Passed" and the incubation is entered as "Passed" in the AIIS.

         2.  If any container still appears abnormal, the inspector holds the lot and follows the procedures listed in the Part 3, Section 2, Abnormal Containers.

Note! Import facilities approved for pre-stamping may have already stamped lots prior to completion of the incubation process.

6. REQUIREMENTS FOR RELEASING PRODUCT PRIOR TO COMPLETION OF INCUBATION

Imported product undergoing incubation testing may be stamped "U.S. Inspected and Passed" and released from the import facility before the tests are completed, provided the producing foreign establishment is not under Intensified for any TOI, all other TOI assigned to the lot have been completed and found acceptable, and the specific conditions listed here in Paragraph VI.C.. were met. However, released lots CANNOT ENTER RETAIL DISTRIBUTION until incubation results are finalized.

1. Application for Approval to Release Product

   1. An importer must submit a written application to the Office of International Affairs (OIA) responsible for the import facility(s) from which product will be shipped. This application must include

      1. To which import facility product might be transported.

      2. How and to which warehouses product might be transported and how control of the product will be maintained.

      3. Guarantees that the product will not be distributed to retail points and lots will be kept intact so that they may be retrieved if a recall is necessary.

      4. A description of the retrieval process.

   2. An application for approval to release product may be made on a lot-by-lot basis or on an annual basis.

2. OIA Approval of Application to Release Product

   2. The OIA may grant permission to an importer to release product before the incubation results are obtained. In doing so, the OIA shall

      1. Write the word "Approved" on the importer's application for approval and sign and date the application.

      2. Make a copy of the approved application and keep it on file in the District Office.

      3. Return the original approved application to the importer

      4.  Send a copy of the approved application to the applicable inspector and circuit supervisor.

   2.  Prior approval for releasing product is not valid for more than one year from the date of the approval.

3. Specific Conditions for Releasing Product

   1. The importer or representative must attach a copy of the approved application to FSIS Form 9540-1, "Import Inspection Application and Report". The application must bear a date of approval by the OIA of not more than one year earlier than the date of the attached 9540-1.

   2. The foreign establishment at which the product was produced must have a good history of compliance for both incubation and condition of container examinations (defined as being Normal in the AIIS). Releasing lots prior to completion of incubation is not permitted if either of these TOIs are on Intensified inspection.

   3. Released lots must be held intact until the importer or representative is notified that incubation results are completed.

4. Notification of Incubation Results

   The inspector notifies the importer or representative about the incubation results. If the lot fails incubation, the inspector notifies the ISLI assigned to the port of entry who shall advise the importer or representative to retrieve the failed lot and present it to the inspector at the import facility of record.

5. Verifying Locations of Released Product

6. Rescinding Approval to Release Product

   1. OIA shall rescind approval to release lots if

      1. Prior to notification of incubation results, the importer representative has allowed product to enter retail distribution or move to any location other than the location stated in the application, or if the lot cannot be readily located.

         OR

      2. The importer or representative fails to present a lot to the inspector upon receiving notification that the lot has failed incubation.

   2. The OIA shall notify the Regional Import Supervisors of action to rescind approval to release lots.

   3. When approval is rescinded in one Region, it shall be rescinded in all Regions. To accomplish this, OIA notifies the Regional Supervisors. The Supervisors shall relay this information to inspection personnel for their area of responsibility.

7. INCUBATION EQUIPMENT FOR IMPORT FACILITIES

Import facilities handling imported thermally processed shelf stable meat and/or poultry products must have the following incubation equipment.

1. An accurate temperature/time recording device. It shall measure temperature at a maximum of 2^o F. increments.

2. An indicating temperature device.

3. An incubator of adequate size, a means for circulating air inside the incubator, and a means to prevent unauthorized entry into the incubator.

The completion instructions listed below coincide with the NUMBERS stated on the middle portion of Form 9550-1 (see Table 88).

1. Unique AIIS Lot Identification Number

2. Lot Number

3. Name of Product

4. Can Weight

5. Name of Country (foreign)

6. Foreign Establishment Number

7. Shipping Marks

8. Chart Identification (I.D.) Number

Enter one number for each chart (e.g., starting at 100 through 999). Also enter this number on the incubation chart.

9. Chart Identification (I.D.)

Enter the amount of acceptable hours per chart.

10. Chart Identification (I.D.)

Enter the total acceptable hours in incubation.

11. Deviations and/or Remarks used to explain any discrepancies.

12. Lot Prestamped?

Check "Yes" or "No"

13. Released Product Prior to Incubation?

Check "Yes" or "No"

14. IN

Month (e.g., 01), Day (e.g., 10), Year (e.g., 03), Time (e.g., 1340), and the inspector's initials at the time the incubation period started.

15. Scheduled OUT

Month (e.g., 01), Day (e.g., 20), Year (e.g., 03), Time (e.g., 1340), and the inspector's initials at the time the incubation period is scheduled to end.

16. Actual OUT

Month (e.g., 01), Day (e.g., 20), Year (e.g., 03), Time (e.g., 1340), and the inspector's initials at the time the incubation period actually ended.

17. Date (Verification)

Date (e.g., 1-12) when the incubation samples were verified. This must be performed daily, when present, but at least twice during the 10-day incubation period.

18. Initials (Verification)

Initials of the inspector who verified the incubation samples.

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