PART 5: EGG AND EGG PRODUCTS

Section 4: Microbial Sampling of Pasteurized Egg Product


I. PURPOSE

This instruction provides import inspection personnel with the procedures for sampling imported pasteurized and imitation/simulated egg products for microbiological testing. The types of inspection issued on these products, at this time, will include Salmonella.

Note: Other types of microbiological sampling may be assigned on a as need basis at the direction of the agency.

The actions to be taken following the receipt of laboratory results are also outlined in this section as well as specific instructions for selecting samples for microbial testing for all pasteurized egg products.

II. FORMS

FSIS Form 10,000-2
Egg Import Shipment Notice for Re-inspection
FSIS Form 5200-8


III. IMPORTED PRODUCTS SUBJECT TO MICROBIAL TESTING

Salmonella testing is applicable for all pasteurized and imitation/simulated egg products.

IV. SUPPLIES

FSIS Form 10,000-2, is used for all Pasteurized and imitation/simulated Egg Product samples.

Inspection Personnel should refer to FSIS Directive 7355.1 for guidance on acquiring sample packaging and sealing supplies.

V. SAMPLING PROCEDURES

1. Obtaining Assignments
   
   Microbiological analysis assignments will be generated by the Egg Database and communicated to inspection personnel on the Egg Import Shipment Notice for Re-inspection

2. Sample Size

   1. Randomly collect at least one pound of product and submit to the laboratory for analysis. When intact packages weigh:

      1. up to five pounds (enough units are collected for a total of at least one pound of product),

      2. Three pounds or more (one sample unit shall be selected),
         * When drilling frozen product for analysis it normally takes twice the volume of shavings to provide 4 fluid ounces.

3. Selecting Samples
   
   Samples are to be randomly selected. Inspection personnel are advised to use the Random Number Generator found in “Other Tools” under FSIS Applications.

4. Lots sampled by FSIS at port of entry at the intensified level must be placed on FSIS hold pending reporting of the lab analyses.

1. Preparing Samples

   1. Inspectors shall submit the entire intact package when possible. Bulks packages will be sampled by collecting 4-individual 4 oz samples for Microbiological Analysis

   2. Sample units shall be REFRIGERATED OR FROZEN when submitted to a laboratory. Note: Shelf stable product is not required to be refrigerated or frozen prior to submitting it to the laboratory.

   3. Inspectors shall complete one FSIS Form 10,000-2 for each lot sampled. The form shall be completed as per instructions in Enclosure 1.

   4. Inspectors shall follow procedures for securing and mailing samples as stated in Part 3, Section 2 General Laboratory Sampling Procedures of the Import Inspection Manual of Procedures.

   5. FSIS Form 10,000-2 shall be enclosed in a separate bag and inserted in a self-sealing bag along with the sample unit. A copy of the form shall be maintained for the case file.

   6. Inspectors will refer to Part 3, Section 1, Enclosure 1, for completing and distributing FSIS FORM 9770-1, Official Receipt of Samples Taken

2. Laboratory
   Sample units shall be mailed to the FSIS Field Service Laboratory (FSL) identified on the.

3. Mailing
   
   Samples shall be mailed via the FSIS contract overnight delivery/courier mailing service. Samples must be shipped Monday through Friday so that they arrive at the laboratory overnight. A sample box shipped on Friday must have a "Saturday Delivery" sticker on it and "Saturday Delivery" marked on the shipping label to avoid delays and discarded samples. Samples must not be shipped on Saturday or on the day before a Federal holiday.

1. Presumptive Positive Notification

   1. When a sample is reported as presumptive positive, OIA, IID-HQ is notified of an import positive through the Biological Information Transfer and E-mail System (BITES).

   2. Inspection personnel shall follow OIA Recall Procedures when notified of a presumptive positive or positive result for microbiological sampling. This includes notifying plant management so that the importer can place product on hold and not distribute the product into commerce, unless the shipment is already on FSIS or Voluntary Hold.

2. Negative Results (Acceptable)
   
   When negative results are reported for the requested analyses, the lot may be released, if held and all other reinspection criteria are acceptable.

3. Positive Results (Not Acceptable)

   1. If a Normal or Increased sample tests positive for Salmonella:

      1. Lot is refused entry if it was on FSIS or Voluntary Hold;

      2. Product in distribution is subject to recall;

      3. Foreign establishment that produced the lot is placed on Intensified until 15 consecutive lots of product from the same process category from that establishment are sampled and reported as “Acceptable” for the involved TOI.

   2. When an Intensified sample tests positive for Salmonella (or other microbiological sampling) the lot is refused entry. The foreign establishment that produced the product will continue on Intensified until 15 consecutive lots of product from the same process category from that establishment are sampled and reported as "Acceptable" for the involved pathogen.

Enclosure 1

FSIS FORM 10,000 -2
Completion Instructions