Current Agency microbiological monitoring programs test samples of raw finished products such as ground beef, ground chicken, ground turkey or the carcasses of steers/heifers, cows/bulls, hogs, and broilers, for Salmonella and ground beef for E. coli O157:H7. In addition, the Agency’s microbiological monitoring programs also tests ready-to-eat finished products for Listeria monocytogenes, Salmonella, Staphylococcal Enterotoxin and E. coli O157:H7.

NMA has debated the value of the Agency’s end product pathogen sampling programs because they do not address the production processes at a point where results could be used to validate or verify a critical control point. In addition, many of the pathogens tested for by the Agency’s monitoring programs have a low incidence rate and do not lend themselves for use as food safety barometers.

The Agency’s public commitment to continue testing end products for the presence of pathogens has challenged industry managers with the prospect of eventuality addressing confirmed findings of a pathogen on their product. Confirmed positive results could initiate product recalls, agency press releases, and enforcement actions ranging from the issuance of non-compliance reports to withholding actions and possibly the suspension of inspection. For example, FSIS Directive 5000.1 indicates that noncompliance with the Salmonella performance standards or Listeria monocytogenes in ready-to-eat products may constitute a failure to maintain an adequate HACCP plan.

The following information has been compiled to help members become aware that they are operating in a strict regulatory environment, where their product must comply with the Agency’s microbiological programs. However, keep in mind that different sampling programs require the application of different strategies:

1. Plant personnel should meet with the assigned FSIS inspector to insure that there is an understanding that notification will be provided during the process of sample collection. Inspection personnel should notify establishments of their intent to sample product (FSIS Directive 10,240.1, Revision 1, Attachment 1). This means that the inspector should notify management before a coded lot is to be sampled, but not necessarily the day or shift before the lot is to be sampled. This should allow plant management the opportunity to hold the entire sampled lot.* If part of the lot has already been shipped, the inspector is not to take a sample from that lot.
2. Prior to sampling, review your GMPs and SSOPs with the inspector. He should actively follow these programs that promote food safety and insure sample integrity. For example, this should prevent him from leaving the slaughter floor to take a sample in your RTE room.
3. Go with the inspector when the sample is taken. This allows plant management the opportunity to voluntarily hold the production lot that the sample represents. It also allows plant management to: collect a companion sample; determine the type of sample taken; identify a specific line or piece of machinery where the sample was taken from; assure the sample was collected randomly and aseptically; assure that the sample represents the current day’s production; verify the point of sampling; and, if it is a ready-to-eat product, if an intact sample was taken.
4. Insure that the inspector takes the sample aseptically. Focus on whether he has a clean gown, shoes and hat. If possible, provide the inspector with a clean gown, shoes and hat that are similar to the articles you provide for your RTE employees.
5. Inspectors should allow plant management to copy laboratory sample forms after the completion of sampling. The copies of these laboratory transmittal forms should be collected as a means of record keeping. Collection of these forms is important as they can be used for future reference when trying to obtain laboratory results.
6. Hold the entire sampled lot.* While this is not a regulatory requirement, plant retention of product may avoid a recall and FSIS press release. Any plant that voluntarily puts a lot on hold, can voluntarily release the product when tests come back negative.
7. After the sample has been taken, completely wash, rinse and sanitize all contact surfaces. Also be sure to re-designate the new lot (with appropriate coding) after the sample is taken as this helps clearly delineate a new production lot. However, in the case of regulatory compliance testing with the Salmonella performance standards, redesignating a new lot is not necessary under normal circumstances.

It is important that you try to follow the above steps to minimize the likelihood of an incorrect test result or an unnecessary recall.

How long does it take to run tests on the sample that the inspector has sent in? Use the following chart as a guide:

If your results haven’t come back in the above number of days, check with your FSIS District Office for a status update or contact NMA’s Regulatory Staff for assistance.

FSIS provides several alternatives to mailing you your lab results. One such alternative is an e-mail distribution system that can cut down mailing time. FSIS is revising its email system and you may experience delays in receiving results. However, once completed, e-mail distribution might be an excellent alternative to mailing. Forms are available upon request; please contact NMA’s regulatory staff at (510) 763-1533.

*NOTE: Except in the case of regulatory compliance or Salmonella performance standards, in which a lot should not be held.