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FSIS Changes in Sampling Frequency for E. coli O157:H7 Testing in Raw Ground Beef – Real or Imaginary Changes?

So, we do not forget what we are really talking about, see the attached "E. coli Movie" – here is the script.

FSIS released "[t]his notice announces that inspection program personnel (IPP) may receive FSIS Form 10,210-3, Requested Sample Programs, for E. coli O157:H7 sampling and testing of raw ground beef products (MT43) at the following monthly rates:

• Up to 4 times within a 30-day window (See block 4 of FSIS form 10,210-3) for establishments with ground beef product production volumes of greater than 250,000 lb/day, as estimated and recorded in block 28 of FSIS Form 10,210-3 each time a sample is collected.  • Up to 3 times within a 30-day window (See block 4 of FSIS form 10,210-3) for establishments with ground beef product production volumes of 50,000 to 250,000 lb/day, as estimate and recorded in block 28 of FSIS Form 10,210-3 each time a sample is collected.  • Up to 2 times within a 30-day window (See block 4 of FSIS form 10,210-3) for establishments with ground beef product production volumes of 1,000 to 50,000 lb/day, as estimated and recorded in block 28 of FSIS Form 10,210-3 each time a sample is collected.  • Generally, no more than once within a 30-day window (See block 4 of FSIS form 10,210-3) for establishments with ground beef product production volumes of less than 1,000 lb/day, as estimated and recorded in block 28 of FSIS Form 10,210-3 each time a sample is collected. However, FSIS will ensure that at these establishments at least one sample is collected quarterly.

FSIS is increasing sampling at high volume ground beef establishments because these establishments produce product that is most widely consumed. The increase in sampling will allow the Agency to estimate the amount of uncontaminated raw ground beef with a higher degree of certainty.  At the weekly meeting following the receipt of this notice, IPP are to discuss with the establishment management:

1. these changes in sampling, 2. the establishment’s lotting procedures, and 3. if the establishment does not already have written procedures for holding lots tested by FSIS, whether the establishment intends to hold the sampled lots.

When more than one sample is scheduled to be collected during the 30-day sample window, IPP are to randomly select a day, shift, and time to collect a maximum of two samples.

• IPP are to collect verification samples within the 30-day sample window starting from the sample collection date indicated in Block 4 of the form, but not before this date.  • IPP may collect two samples per day as long as each sample corresponds to a microbiologically independent and individually identifiable lot of product. However, IPP are not to collect two samples per day if the establishment cannot continue to operate under that sampling frequency (e.g., because the establishment cannot fill orders and hold all sampled product) or because the inspection program personnel’s workload cannot accommodate that sampling frequency. Under these circumstances, IPP should collect a single sample.  • In all cases, IPP are to collect at least one sample per FSIS Form 10,210-3 whenever a sample request form is received and product is produced and available during the 30-day window.

At establishments producing more than 250,000 lbs/day, IPP may find that the establishment has written procedures to grind a minimum batch of product that represents the entire lot in a smaller grinder. Establishments with these written procedures will typically have supporting documentation that describes why their minimum batch is representative of the entire lot. In such cases, IPP are to sample this minimum batch of product after randomly selecting the day, shift, and time and notifying the establishment as set out in FSIS Directive 10,010.1.  IPP may submit one or more individually identified samples per box and are to follow FSIS Directive 7355.1 Use of Sample Seals for Program Samples and Other Applications. If necessary, they are to include additional cooling packages in the box to keep the sample or samples cool during transportation. To submit multiple samples, IPP may request larger boxes from the laboratory identified in Block 9 of FSIS Form 10,210-3 by sending an e-mail message to their e-mail addresses for sampling supplies.

To request any needed sample supplies, IPP are to contact the laboratory listed in block 9 of the form via e-mail and request sampling supplies using the following e-mail addresses:

Sampling Supplies – Eastern Lab
Sampling Supplies – Midwestern Lab
Sampling Supplies – Western Lab

IPP should request sampling supplies via e-mail at least 72 hours before sampling is to begin, and include the following information to ensure a prompt response from the laboratory:

a. establishment number,
b. daytime phone number,
c. project code, and
d. any supplies needed.
Reminder, IPP are to verify and update the Performance Based Inspection System Establishment Profile Extension Product Volume information to ensure that it remains accurate. Also, as needed, IPP are to update PBIS the Establishment Profile, Processing Tab Screen, HACCP Processing Categories, Raw Ground Product (03B), which identifies the processing categories and types of products.

Analysis of the Data

The Office of Public Health Science and the Office of Data Integration and Food Protection will analyze sample results for E. coli O157:H7 in raw ground beef. Specifically, the Office of Public Health Science will produce a weekly report on sample findings, along with an annual summary report that will be published on the FSIS internet. The Office of Data Integration and Food Protection will analyze the sampling data to identify trends (e.g., geographical, seasonal) and to evaluate program effectiveness (e.g. sample scheduling and collection rates). In addition, that office will use the data to calculate a quarterly performance measure of E. coli O157:H7 in raw ground beef that will be included in the Agency’s quarterly performance report.

Our Thoughts:

Whether this is a statistically-significant increase in testing is impossible to determine because there is no explanation as to what constitutes pulling a sample at random.  And the discretion to pull two samples in one day is anything but random.  But even assuming that the samples are pulled in some truly random fashion, the increase in frequency appears meaningless.  It is still an exercise in hunting for a needle in a very large haystack—i.e., four times PER MONTH in a plant producing in excess of 250,000 pounds of ground beef PER DAY. 
Also, telling is the fact that plants will apparently have the discretion as to whether to hold the tested lot.  (Under the current protocol, plants are typically required to hold the lot from which the sample is pulled until the sample comes back presumptively negative, at which point the lot is released.  If the sample tests presumptively positive, the lot continued to be held until confirmatory testing is done.  Of course, most plants, at that point, just send the held lot to a cooking plant rather than wait for the confirmatory test results.  This has  the “beneficial” effect of not having a confirmed positive test attributable to the plant, since FSIS usually does not proceed with the confirmatory testing if the sampled lot is sent for cooking.) 
FSIS also allows plants to define lots anyway they want, so there will be no way to truly compare the test results.  So, for example, one plant may define a lot as one hour of production, while another plant may define a lot by weight, or the contents of a single grinder-load.  As a result, positive test results will not tell you anything about the relative prevalence of
E. coli O157:H7 in ground beef.
Finally, I assume that multiple positive test results will, as before, prompt FSIS to perform a Comprehensive Food Safety Assessment of the plant. But that is not stated in this new policy.  One could argue as well that a single positive is evidence that the plant’s HACCP plant has failed and must be revised and re-validated. 
Bottom-line: As the FSIS has been operated to-date, the Agency and the meat industry share an equal interest in not finding
E. coli O157:H7 in plants because it proves both entities to be failures.  So the politics of testing is all about creating PR for the appearance of more stringent testing that is in fact not more stringent at all.  Increased frequency does not, by itself, mean increased stringency.

Also, where is the "transparency?"  All inspected facilities should have a "science-based" testing protocol that helps validate its HACCP.  All test results should be shared with FSIS.
I would add one final thing: If FSIS really wants to get serious, it should re-implement retail sampling and do it in a meaningful way, rather than using the public as a kind of “canary in the coal mine” to evidence how much E. coli O157:H7 there is in the meat supply.

Also – REMEMBER – they are only testing for E. coli O157:H7, not other shiga-toxin E. coli.  See, Marler Clark has Tested Retail Hamburger for Non-O157:H7 Pathogenic Shiga Toxin Producing E. coli – Abstract Available