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REGULATIONS AND DIRECTIVES DEVELOPMENT


Performance Standards for Salmonella on Carcasses and on Raw Ground Product

Draft

Talking points prepared for delivery by Philip Derfler, Deputy Administrator, Office of Policy, Program Development and Evaluation, before the National Advisory Committee on Microbiological Criteria for Foods, Washington, DC, May 7, 2001.


Introduction

  • Hello. Mr. Billy has introduced you to pathogen reduction, HACCP, and performance standards. In my remarks, I will provide you with some more details about the performance standards that FSIS has adopted. In particular, I will talk about the performance standards for Salmonella on carcasses and on raw ground product.

  • I will discuss three key aspects of these performance standards:

1) why FSIS chose Salmonella as the target organism for pathogen reduction;

2) how FSIS arrived at the levels in the performance standards; and

3) how FSIS ensures compliance with the performance standards.

  • Please keep in mind that FSIS has in place, or has proposed, Salmonella performance standards for other product classes, such as for certain cooked meat products. These standards have a very different function, and were designed in a very different way, than those about which I will be speaking. Today, I will talk only about the Salmonella standards for the carcasses and raw ground products. Those standards are the ones involved in the questions that the Agency is asking you to address.

 

So --- Why Salmonella was chosen as the target for pathogen reduction ?

  • As Mr. Billy stated earlier, HACCP and performance standards are intertwined in the Agency?s regulatory strategy for improving food safety.

  • In the pathogen reduction/HACCP final rule that FSIS promulgated in 1996, the Agency gave four reasons for why it considered Salmonella to be the appropriate organism to use as the measure of performance in pathogen reduction. First, Salmonella is a problem pathogen. It is among the most common causes of foodborne illness associated with meat and poultry products. Second, Salmonella is relatively easy to find. Current testing methodologies can recover Salmonella from a variety of meat and poultry products. Third, Salmonella is a useful indicator. Interventions aimed at reducing Salmonella are likely to be beneficial in reducing contamination by other enteric pathogens. Finally, it is relatively easy to determine what is happening with Salmonella. It occurs at frequencies that permit changes in its occurrence to be detected and monitored.

These four factors make clear that FSIS chose Salmonella as its target because it would provide a ready indication of whether SSOPs and HACCP were succeeding in controlling and reducing pathogens.

 

How were the levels in the Salmonella performance standards determined?

  • The Pathogen Reduction/HACCP systems final rule sets pathogen reduction performance standards for Salmonella that must be met by all slaughter plants and all plants that produce raw ground products. There are separate performance standards for carcasses of cattle (one for steers/heifers and one for cows/bulls), for market hog carcasses; and for young chickens. There are also pathogen reduction performance standards for ground beef, ground chicken, and ground turkey.

  • The pathogen reduction performance standards for Salmonella are based on FSIS data collection efforts, which are referred to as "baseline studies." There was a separate baseline study for each product category. The Agency used the results of these baseline studies to provide a national estimate for each product category of the percentage of product that contains Salmonella. In the final rule, FSIS concluded that these national estimates of Salmonella prevalence were the best available data on which to establish Salmonella performance standards.
  • So the performance standards have been set based on the national estimates of Salmonella prevalence. For example, the standard for ground beef is 7.5% because the results of the baseline study support a national estimate that 7.5% of ground beef contains Salmonella.

The performance standards are not, however directly translatable into an enforceable measure. After developing the standards, the Agency sought to design a sampling approach for determining whether an establishment is meeting the applicable standard. The Agency decided to measure individual plant performance using a series of sample sets. FSIS defined sample sets based on two parameters: The number of test results in the set and the maximum number of positives that can occur with there still being compliance.

As for the former factor, FSIS decided that the set size should be greater than 50, so that in doing sampling, FSIS would be measuring process control over time. As for the number of positives, FSIS set these numbers so that establishments that are operating at the performance standard, that is, at the national prevalence level, would have an 80% probability of passing the set. The preamble to the final rule explained that. FSIS decided to choose the 80% level based on a balancing of three factors: The need to prevent establishments from failing to meet the standard based on chance results, the need to ensure that plants that were not meeting the standard would be readily detected, and the need to give plants an incentive to perform beyond what would be minimally required.

  • Given the decisions to use a set size over 50 and an 80% probability of passing at the standard, the number of samples to be taken and the number of positives to achieve the standard in a set were determined using binomial probability distribution. To explain how this distribution works would take a statistician, but for the performance standard for ground beef it means that even though the standard is 7.5%, a plant will be considered to meet the standard if, of 53 samples that are to be taken, 5 or less are positive.
  • The approach that FSIS used in setting the performance standards results in the levels of performance that establishments must achieve varying from product class to product class. This fact has led some to complain about inequities in the standards; for example, that broilers can be 20% positive for Salmonella and pass, while steers and heifers can only be 1.0% positive to pass. The standards are consistent however, because, what is required is the same for all establishments. They must achieve at least the baseline level of performance for the product classes that they produce.
  • It is important to note that the Salmonella performance standards are not based on a quantitative assessment of the risk posed by any particular incidence of contamination, nor on a determination of a "safe" incidence or level. In other words, the levels are not based on how much Salmonella it takes to make a person sick. There is not an adequate scientific basis for making such an assessment.

  • The Salmonella performance standards are instead based on the public health judgment that reducing the percentage of product with Salmonella will reduce the risk of foodborne illness, and that what it is important for an establishment to demonstrate is that it is able to control the occurrence of pathogens in its product; that is, that it is able to consistently produce product that meets the performance standard.

  • Data collected in 2000 indicate that Salmonella prevalence in each of the product categories subject to performance standards has dropped since HACCP implementation, and that, overall, 90% of all plants tested are meeting the standards.

  • Despite these encouraging results, there has been some concern within industry that the standards are too stringent. The Agency?s response to these concerns is this: It is feasible for all establishments to meet or exceed the baseline prevalence of contamination with Salmonella, particularly if they maintain sanitary conditions under their Sanitation Standard Operating Procedures and operate in accordance with adequate, validated HACCP systems. This fact is strongly supported by the results of the testing that FSIS has done, which, as I stated, show that most establishments are meeting the standard.

How does FSIS enforce performance standards?

  • It is important to point out that establishments must meet the Salmonella performance standard not on a lot-by-lot basis, but consistently over a period of time. In other words, the standards for raw product are not used to judge whether specific lots of product are adulterated under the law. Rather, the standards are intended to be a basis on which to evaluate the adequacy of an establishment?s HACCP system for controlling and reducing hazards, including pathogenic bacteria on raw products.

  • FSIS determines an establishment?s compliance with the Salmonella performance standard by taking the appropriate number of samples, generally at the rate of one per day, testing each sample for Salmonella, and determining whether the number of positives is above the maximum permitted for that product.

  • The Agency?s goal is to achieve pathogen reduction by ensuring that all slaughter and raw ground establishments meet the performance standards established by FSIS. Enforcement is based on a two-part testing program: ongoing testing, which includes all establishments at regular intervals irrespective of performance, and targeted testing, focused on establishments that have been unable to meet the standard.

  • If ongoing or targeted testing in an establishment evidences that the performance standard is not being met, then FSIS will decide whether to conduct follow-up testing on the basis of several factors.

  • FSIS initiates another set of tests immediately at all establishments with test results that significantly exceed the standard.

  • If an establishment has Salmonella test results marginally above the limit and takes corrective action, FSIS will decide that immediate follow-up testing is not necessary. If, on the other hand, that establishment were not to take meaningful corrective action, or if it took no action at all, then FSIS would immediately institute another series of tests, despite the fact that the results were only marginally above the standard.

  • If the establishment fails the second targeted series of tests, then it is required to reassess its HACCP plan for the tested product and to modify the plan as necessary to achieve the Salmonella performance standard.

  • If the establishment fails to reassess its HACCP plan or to make the modifications in its plan that the reassessment suggests, or if it fails the third series of targeted tests, FSIS will give the establishment notice that it intends to suspend inspection services. If entered, the suspension would remain in effect until the establishment comes forward with a credible plan for modification of its HACCP plan that will likely enable it to meet the performance standard.

Closing

  • I would like to close by reiterating what I think are some of the most important points to remember about the Salmonella performance standards for carcasses and raw ground product.

  • First, the standards are based on what FSIS concluded were the best data available on the prevalence of Salmonella in raw products. The standards were established based on FSIS' public health judgment that reducing the percentage of carcasses and of ground product with Salmonella will reduce the risk of foodborne illness.

  • Second, we know that the Salmonella performance standards are achievable because they are based upon a nationwide baseline survey of what establishments were achieving prior to HACCP implementation. In fact, the overwhelming majority of plants have been able to meet or exceed the standards since they were implemented.

  • Third, the Salmonella standards are not for use in judging a specific product, but instead they are used to evaluate the performance of an establishment.
  • Finally, as Mr. Billy said, there is reason to believe that the Salmonella standards are working. Salmonella levels are down in the products for which standards have been set, and there is at least the suggestion in the CDC FoodNet data that foodborne illness is down as well.

 

-END-

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