How does finding a positive E. coli O157:H7 indicate an inadequate HACCP plan for raw grinding operation?(9-03)

One E. coli O157:H7 positive result, in and of itself, does not indicate an inadequate HACCP plan. It does indicate that there is a food safety hazard in the product represented by the sample. The HACCP regulations (9 CFR, Part 417) require that the HACCP plan be designed to prevent, eliminate, or reduce to an acceptable level all identified food safety hazards. A positive E. coli O157:H7 result indicates that the HACCP system was not effective in preventing, eliminating, or reducing to acceptable levels that hazard in that part of production.

a. Why does the grinder have to reassess in that situation?

Whether a grinder is required to reassess its HACCP systems or not depends on the situation. If the grinder determined that E. coli O157:H7 is not a food safety hazard likely to occur and receives a positive result, a reassessment is required under the provisions of 9 CFR 417.3(b)(4) as part of the corrective actions to determine if the unforeseen hazard should be incorporated into the HACCP plan. If the grinder has considered E. coli O157:H7 to be a food safety hazard that is reasonably likely to occur, reassessment is not specifically required by 9 CFR 417.3(a). However, as the establishment identifies the cause of the E. coli O157:H7 contamination, and implements measures to prevent recurrence, it may be appropriate in some cases to include a reassessment of all or part of the HACCP plan in the corrective action process.

Industry understanding that agency will only test if the plant has the opportunity to hold the product.(7-04)

The determinations of whether to hold product, and of how much product to hold, is up to the establishment. FSIS directs inspection personnel to notify the official establishment that FSIS will be collecting a sample and to provide enough time to allow the establishment to hold any product that the establishment feels may be affected by a positive sample result.

Can we correlate MPR and Aw? (7-04)

Yes. MPR and aw are related, but the relationship is very product formulation specific. One can easily establish a correlation between MPR and aw for a given formulated product by determining the moisture and protein content of the product and comparing that ratio to the determined aw. However, if you change the product formula, such as adding sugar or changing the salt content, you would not change the MPR, but could significantly change the aw of the product. The aw of the product is a measure of the amount of available water in the product. Any product ingredient that can influence the availability of water, such as solutes (salt, sugars, etc), and starches, etc, will have an effect on the water activity. Certain proteins (vegetable proteins, hydrolyzed proteins, milk, egg, etc) can also have a significant effect on aw, as well as the protein content. Therefore, the relationship of MPR to aw is significantly affected by the product formulation.

How can a grinder prevent being in a recall, because of an E. coli O157:H7 positive at another plant using the same lot of raw materials?(7-04)

A grinder that wants to prevent being in a recall because of an E. coli O157:H7 positive at another plant that used raw materials from the same lot of product must have a means of justifying that the sub-lot is not affected by the positive result at the other establishment. This justification could be provided by the grinding establishment having, for example, a testing program that provides high statistical confidence contamination will be detected or by other means.

Salmonella Reassessment (in poultry slaughter)(9-05)
a. What are the goals?
b. Is it just fact finding?

FSIS is concerned about the recent upward trend in Salmonella positive test results in the poultry industry. The goals of the food safety assessments in poultry slaughter operations are to determine whether the establishments have identified Salmonella as a food safety hazard and to verify that the food safety systems are designed to control these organisms.

Listeria Sampling(9-05)
a. What is the direction of the new intensified sampling?

The Intensified Verification Testing (IVT) program (for cause) has not been altered. There will be the introduction of a new Routine Lm Risk-based (RLm) sampling program within the next few months. It involves a verification testing program of the food contact surfaces, environmental (non-food contact) surfaces, and intact product. Only FSIS personnel that have completed the IVT training will be performing this testing.

b. What is the agency’s position on giving plants adequate notification for USDA environmental/product sampling to minimize overall business impact?

FSIS will issue a directive to inspection program personnel that provides them with directions for giving plant management adequate notification to allow the establishment to hold all product represented by the samples.

c.What results are coming in?

The list for conducting the Routine Lm Risk-based Food Contact, Environmental (Non-food contact), and Intact Product Testing “shakedown” phase one included 13 plants from different districts. The results were not made public, but positives were reported from FCS and environmental sites. A report was requested on the results and lessons learned through the trial phase of RLm testing to be included in the preamble of the Lm final rule. The final rule is in the clearance process.

d.What kind of training do inspectors have for sampling? What are future training plans?

The EIAO or PHV will be responsible for the sample collection. They have received formal IVT training delivered through the Center for Learning, College Station, TX

Are there grants available for small companies for sampling?(9-05)

No, FSIS does not have authority to issue these type of personal use grants. FSIS is authorized to use cooperative agreements to reflect a relationship between FSIS and other Federal agencies, States, or cooperators to carry out educational programs or special studies to improve the safety of the nation's food supply. FSIS will engage in cooperative projects that will achieve measurable enhancement of the Nation's public health through food safety.

Is there policy for plants to use government sampled test results?(9-05)

Currently there is no FSIS policy preventing an establishment from using Agency test results However, these data tend to be very limited and might not be adequate to address the establishment’s needs. The decisions made by plants within their food safety systems often need specific documentation not available in government sampling results.

There are many sources of data to support decisions that are available from academic and other organizations and resources available to plants. Information and help is available from FSIS Small/Very Small Plant Outreach at the following site: www.fsis.usda.gov/Science/Small_Very_Small_Plant_Outreach/index.asp

Is FSIS going to be doing new Routine Lm risk-based sampling this year?(7-06)

Yes, Routine Lm risk-based sampling has already been implemented.

How many plants will be sampled and how are these plants selected? (7-06)

Approximately one plant per district per month, based on risk. Plants are selected randomly, but plant history can also be factored into the frequency of testing for an individual plant.

When running heat treated product after fully cooked product, if the fully cooked product were to test positive (e.g., for E. coli, Salmonella, or L. monocytogenes), would subsequent heat treated product be affected even though it is not fully cooked?(7-06)

Post-lethality exposed ready-to-eat (RTE) product is adulterated if it passes over a Lm positive food contact surface. The establishment should address this situation through hazard analysis to decide whether the cooking instructions for the not fully cooked product are adequate, or if the pathogen load might be too high for the cooking instruction provided.

As a raw ground beef processor, how can I be sure that the raw beef I receive with a COA is E. coli O157:H7 free? And that product received with a fully cooked COA is Lm free?(7-06)

A Certificate of Analysis (COA) describes quality control data for a particular lot/batch of product. A COA only provides results from a 25 gram sample of the lot/combo to provide information on slaughter plant controls to prevent E. coli O157:H7. However, it does not state that the entire lot is E. coli O157:H7 “free”. An establishment must verify in some manner how their purchase specification is being met. This could be by testing the received product at some supportable frequency, or alternatively, the establishment may audit the supplier to see that their supplier interventions are effective in eliminating or reducing this organism to an undetectable level. The same logic applies to L. monocytogenes sampling. However, should the receiving establishment receive “irradiated” product with a COA or “cook-in-bag” product with an accompanying COA, FSIS would then expect these types of products to be E.coli O157:H7 and/or Lm free.

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