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| The FSIS Microbiological Testing Program for Ready-to-Eat (RTE) Meat and Poultry Products, 1990–2010 |
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INTRODUCTION
FSIS has conducted a regulatory microbiological testing program on Ready-To-Eat (RTE) meat and poultry products since 1983. The data
reported here are from sampling projects covering the years 1990 through 2010. These data do not include the results of follow-up
sampling that FSIS conducts in response to a positive result. FSIS analyzes the samples for microbial hazards of public health concern.
FSIS also analyzes samples of RTE egg products for Salmonella, but these results are not included here. FSIS laboratories
located in Alameda, Ca., St. Louis, Mo., and Athens Ga., perform all regulatory analyses of RTE products. All text, tables, and graphs
prior to 2008 are reported by sample completion. Beginning in 2008, results are reported by sample collection within the calendar year
to better align FSIS' activities with those of other federal partners. The Agency does not anticipate this change to have an effect on
the results presented. Throughout the history of the FSIS microbiological RTE regulatory sampling program, the individual projects
evolved in response to public health concerns. The data reported here include individual sampling projects implemented under the overall
RTE program. Although not designed to test for statistically significant changes from one year to the next, the aggregate data provide
an overall indication of trends.
Ready-To-Eat Timeline:
1983-2004—Establishments were randomly selected for regulatory samples from different sub-populations or from the total
population of establishments producing RTE products.
2005—FSIS implemented RTE001, a new project aimed at selecting establishments for sampling based on different risk factors for
L. monocytogenes. RTE001 is described below in 2005 results.
2006—FSIS implemented RLm, phase 2 of L. monocytogenes risk-based sampling program. RLm includes sampling of products,
product contact surfaces, and environmental surfaces in conjunction with a comprehensive Food Safety Assessment (FSA).
FSIS Directive 10,240.5 (February 3, 2009) provides direction to Enforcement, Investigations, and Analysis Officers (EIAOs) and Public
Health Veterinarians (PHVs) trained in the EIAO methodology for collecting samples under the RLm sampling project. RLm samples are
analyzed only for L. monocytogenes.
2007—FSIS modified RTE001 after an incident where an unusual proportion of a product using growth inhibitors was found to be
L. monocytogenes positive. The risk-based algorithm was adjusted to ensure that more products using antimicrobials or growth
inhibitors were sampled. During April of the same year, FSIS modified the algorithm to ensure that 50 percent of the samples each month
were scheduled in establishments reporting production of products with an antimicrobial or growth inhibitor but without any post
exposure pasteurization (i.e., Alternative 2b products). The algorithm directed the majority of samples to establishments using sanitation
alone to control L. monocytogenes in RTE products (i.e., Alternative 3). For more information of post lethality alternatives
please see 9 CFR 430.3.
There is no way to assess what effect this modification had on the overall CY 2007 results for RTE001.
2009—In August, FSIS began compositing the five environment samples taken as part of the RLm sampling program to allow
FSIS to increase the number of establishments scheduled each month from 15 to 45.
In establishments selected for non-RLm testing, the inspection program personnel (IPP) send a sample request form identifying the sampling
project, the microbial hazard(s), and the FSIS laboratory where the analysis will take place. The form also identifies a window of time to
collect a sample. FSIS Directives contain additional guidance for how to select the product for sampling. After identifying the product or
product category, IPP randomly select the sample. All samples (except RLm) are analyzed for Salmonella and L. monocytogenes. Dry and semi-dry
fermented sausages and cooked beef patties are also analyzed for Escherichia coli O157:H7.
The product resulting in a positive sample must be reprocessed or destroyed. Most establishments voluntarily hold all RTE product pending
notification of the FSIS laboratory test results. If all product implicated by a positive laboratory result is not under the establishment's
control, then the producing establishment must take steps to remove adulterated product from distribution channels and/or commerce, which
may entail a voluntary recall.
FSIS revised the previous nomenclature with the posting of the CY 2004 RTE microbiological testing program results. FSIS now reports results
as both the number and percentage of analyzed samples that have tested positive for Salmonella or L. monocytogenes.
Previous postings described these results as "prevalence." However, the term "prevalence" may imply that results from the regulatory
sampling projects are statistical estimates of national product prevalence. To avoid confusion, FSIS will now only use "prevalence" to
describe testing results from nationwide baseline studies specifically designed to provide statistically valid baseline estimates of
national product prevalence for various microorganisms and for regulatory purposes. Results of regulatory testing projects conducted
to verify the effectiveness of food safety systems are reported as the percent of analyzed samples that tested positive.
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THE 2010 RESULTS
Tables 25 and 26 present
results for CY 2010. Beginning January 2008, FSIS began reporting results based on sample collection date rather than analysis completion
date. In November 2009, the 10 product category list used from 1983 through 2008 was modified to include at least eight additional
product categories based on a blend of both product type and process type. The 2009 modification prevents a direct comparison of results
with subsequent years due to different product codes. Tables 25 and 26
provide the results of the total number of RTE samples analyzed in CY 2010 for Salmonella and L. monocytogenes, respectively.
In CY 2010, FSIS analyzed 3,152 samples for Salmonella in the ALLRTE sampling project and 8,704 samples in the RTE001 sampling
project (Tables 25). Of the 11,856 samples analyzed in both the ALLRTE and RTE001
sampling projects, there were four positive samples (one from ALLRTE and three from RTE001), resulting in a 0.03 percent positive rate.
Table 26 presents the total number of products analyzed for L. monocytogenes
in the ALLRTE, RTE001, and the risk-based L. monocytogenes (RLm) sampling projects. FSIS analyzed 3,153 and 8,704 samples for
L. monocytogenes in the ALLRTE and RTE001 sampling projects respectively. Ten positive samples were observed in ALLRTE (0.32
percent positive), and 24 positive samples were observed in the in RTE001 samples (0.28 percent positive). FSIS analyzed 1,854 products
(RLMPROD) for L. monocytogenes in the RLm sampling program in CY 2010. The sampling results produced four positives samples,
resulting in 0.22 percent positive rate.
FSIS analyzed 13,711 samples in CY 2010 for L. monocytogenes, excluding all follow-up, investigative and imported samples,
resulting in a 0.28 percent positive rate (38 positive samples) across all projects (Table 26).
The numbers presented in Table 26 do not include the 6,393 samples of food contact
surface and 668 composited environmental samples analyzed as part of the RLm sampling program in CY 2010.
FSIS analyzed 13,711 samples, which included L. monocytogenes, Salmonella, and/or E. coli O157:H7 in all the
RTE sampling projects in CY 2010. Data from follow-up and imported samples are not included.
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THE 2009 RESULTS
Results for CY 2009 are presented in Tables 23 and 24.
As mentioned earlier, beginning January 2008, FSIS started reporting results based on sample collection date, unlike prior years,
where results were reported based on analysis completion date. Therefore, 2009 results are reported based on sample collection date.
The 10 product category list used from 1983 through 2008, was modified in November 2009, to include at least 8 additional product categories
based on a blend of both product type and process type. This modification should improve the effectiveness in the analysis of
RTE product testing results. Due to the modification made in 2009, CY 2009 results are reported based on the sampling projects
(RTE001, ALLRTE, and RLmProd), and not on product categories as in prior years. Therefore, the product category results in CY 2008
cannot be compared with CY 2009, since different product codes were used in 2009, but summary results from the sampling projects in
CY 2009 can be compared with the summary results of CY 2008, since results from both years are presented based on the sample collection
date. The results of the total number of RTE samples analyzed in CY 2009 for Salmonella and L. monocytogenes
are presented in Tables 23 and 24 respectively.
A total of 2,761 samples were analyzed for Salmonella in the ALLRTE sampling project and 8,158 in the RTE001 sampling project in
CY 2009 (Table 23). Of the 10,919 samples analyzed in both the ALLRTE and RTE001 sampling projects, there were 4 positive samples
(one from ALLRTE and three from RTE001), resulting in a 0.04 percent positive rate.
Table 24 represents the total number of products analyzed for L. monocytogenes in the ALLRTE, RTE001, and the risk-based
L. monocytogenes (RLm) sampling projects. A total of 2,761 and 8,158 samples were analyzed for L. monocytogenes in the
ALLRTE and RTE001 sampling projects respectively. Seven positive samples were observed in the 2,761 ALLRTE samples analyzed
(0.25 percent positive), and of the 8,158 samples analyzed in RTE001 sampling project, there were 35 positive samples (0.43 percent positive).
The RLm sampling program was modified in September 2009, to include 45 establishments per month, and establishments were scheduled using
a risk-based algorithm, that takes into consideration the level of inspection, production volume, control alternative, and sampling
history of the establishment, similar to the risk-ranking algorithm that was used prior to 2008. A total of 1,351 products (RLmProd)
were analyzed for L. monocytogenes in the RLm sampling program in CY 2009. Of the 1,351 samples analyzed, 3 positives
samples were observed, resulting in 0.22 percent positive rate.
A total of 12,270 product samples were tested in CY 2009 for L. monocytogenes, excluding all follow-up, investigative, and
imported samples, and a 0.37 percent positive rate was observed (45 positive samples) across all projects (Table 24). The numbers
presented in Table 24 does not include the 4,524 food contact surface and 1,168
environmental samples that were analyzed as part of the
RLm sampling program in CY 2009.
The total number of product samples analyzed for L. monocytogenes, Salmonella, and E. coli O157:H7 in all the
RTE sampling projects in CY 2009 was 23,699. Follow-up and imported samples are not included.
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THE 2008 RESULTS
The results for CY 2008 are presented in Tables 21 and 22.
Prior to 2008, results were reported for analyses of samples completed by the end of the calendar year. Beginning January 2008,
results were posted to include all samples collected within the calendar year, to better align FSIS' activities with those of other
federal partners. The Agency does not anticipate this change to have any effect on the results presented. The 2008 results cannot
be compared directly with results from previous years, since data from previous years is reported by the date the analysis was
completed (analysis end data). The 10 product categories introduced in CY 2001 and listed in Table 4 were continued for CY 2008.
Therefore, all results are organized around those 10 product categories. The results from CY 2008 for Salmonella and
L. monocytogenes are presented in Tables 21 and 22 respectively.
The total number of samples analyzed for Salmonella for both the ALLRTE and RTE001 sampling programs in 2008 is shown in
Table 21. Of the 12,041 samples analyzed, 5 positive samples were observed,
resulting in a percent positive rate of 0.04.
The total number of products analyzed for L. monocytogenes in 2008 is presented in
Table 22. All samples analyzed for the ALLRTE, RTE001, including
the product sample results from the Routine Risk-based L. monocytogenes sampling program (RLm), designated as RLmProd is shown
in Table 22. RLmProd, indicates that only the product component of the
RLm sampling program is reported. In September 2008, the FSIS implemented some changes to RLm Sampling Program. The RLm program was
modified to include establishments producing 95% of the domestic volume of RTE meat and poultry products, instead of the risk-ranking
algorithm previously used. A total of 13,001 product samples were tested for L. monocytogenes in CY 2008, excluding all
follow-up sampling and sampling of imported products. The percentage of positive product samples across all projects was 0.42%.
Table 22 does not include the 5,047 product contact surface and
environmental samples that were analyzed as part of RLm sampling program.
The total number of analyses for L. monocytogenes, Salmonella and E. coli O157:H7 performed on RTE samples
in CY 2008 was 30,644. This number does not include follow-up and import samples.
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DISCUSSION
FSIS does not view the results of regulatory testing as estimates of national product prevalence. The Agency, however, does consider the
RTE regulatory results to be an excellent indicator of the trends in pathogen presence in RTE products over several years. The Agency
implemented the ALLRTE project in order to have L. monocytogenes results to compare with earlier years (before CY 2004) as the
Agency moved to make its RTE projects less random and more risk-based.
In 2007, the Agency recognized that sampling changes limited the use of ALLRTE results as a trend indicator. ALLRTE was designed to obtain
random samples across the full range of RTE products and establishments producing an RTE product. FSIS schedules many establishments
every month under RTE001; therefore, the establishments are not routinely sampled under ALLRTE. Because of continuing concerns about
ALLRTE as a trend indicator, the Agency included two graphs illustrating the trend in results from regulatory sampling for Lm.
One graph used the ALLRTE results from CY 2004 through CY 2010. The second graph
used the sum of all product sampling from each year, regardless of sampling type.
For CY 2010, FSIS analyzed 11,856 samples for Salmonella in both the RTE001 and ALLRTE sampling projects. Four positive samples were
observed with a 0.03% positive rate (Table 25).
The 3,152 ALLRTE samples produced one positive sample, resulting in a 0.03 percent
positive rate. The 8,704 RTE001 samples produced three positive samples, resulting in a 0.03 percent positive rate (Table 25).
For CY 2010, FSIS analyzed 13,711 product samples for L. monocytogenes (Table 26).
The 3,153 ALLRTE samples produced 10 positive samples, resulting in a 0.32 percent positive rate (Table 26).
For CY 2009, the 2,761 ALLRTE samples produced seven positive L. monocytogenes, resulting in a 0.25% positive rate
(shown in Figure 1). Figure 1 illustrates the percent of
RTE regulatory samples positive for L. monocytogenes from 1990 through 2010. The results include all the RTE sampling programs
from 1990 through 2003 and the ALLRTE sampling program from 2004 through 2010. Figure 2
illustrates the percent of RTE regulatory samples positive for L. monocytogenes from 1990 through 2010, using all product sampling
programs. The data shows a continuing and consistent decline in the percent of positive samples in the projects where FSIS analyzes RTE
meat and poultry products for L. monocytogenes from 1990 to 2010.
For CY 2010, the RTE001 sampling program identified 24 positive L. monocytogenes results from the 8,704 samples analyzed, resulting
in a 0.28 percent positive rate. For CY 2009, the RTE001 sampling program identified 35 positive L. monocytogenes results from the
8,158 samples analyzed, with a positive rate of 0.43 percent.
FSIS analyzed 1,854 product samples for L. monocytogenes in the RLm sampling program in CY 2010. These samples produced four
positive samples, resulting in a 0.22 percent positive rate (Table 26). For CY 2009 the
RLm program analyzed 1,351 RLm product samples for L. monocytogenes. The results produced three positive L. monocytogenes
product samples, resulting in a 0.22 percent positive rate (Table 24). Data from
CY 2008 to present cannot be compared to previous years because of the change in how the sample collection is identified. In addition
to collection date, the RLm sampling program was modified in CY 2008 to include all domestic establishments producing 95% RTE meat and
poultry products. In September 2009, the program was altered to include the risk-ranking algorithm, which scheduled 45 establishments per
month. Previous years applied a risk ranking algorithm that scheduled 15-17 establishments per month.
The RTE001 sampling project remains a risk-based project that targets the higher risk product categories of deli meats and hotdogs.
This project is now the primary method where inspectors collect a single product on a specific day. The RLm project complements the RTE001
project.
The 10 product categories introduced in December of 2000 identify factors that could affect the probability of product contamination during
post-lethality exposure or effectiveness of the kill step. Over the past several years, these product categories have appeared to provide some
differentiation in the results, at least in the area of potential for post-lethality exposure to L. monocytogenes. For example,
FSIS CY 2004 data indicated that the highest percentage of samples positive for L. monocytogenes in each year had been in the
sliced, diced, and shredded product category where exposure to product contact surfaces would be considered high. From 2001 through 2004,
FSIS had analyzed samples from 5,143 sliced, diced, or shredded products and recorded 91 positive results (1.77 percent positive).
In CY 2005 and CY 2006, the percentages of positive samples for sliced and diced products were noticeably lower, 0.67 percent and 0.83 percent,
respectively. In CY 2007, FSIS analyzed 3,408 samples of sliced and diced products and found positive results in only 0.38 percent, a
dramatic change from the 2.59 percent positive of CY 2001. For CY 2007, the highest positive rate was for multi-component products at 0.88
percent (12 positives in 1,356 samples). Examples of multi-component products include sandwiches or wraps, as well as dishes, such as
lasagna and chicken fried rice. Sliced, diced, or shredded products had the highest number of positive samples in both the ALLRTE and RTE001
projects. In CY 2008, ALLRTE had a 0.45 percent positive rate across all product categories but a 0.79 percent positive rate in the sliced,
diced, and shredded product category. Similarly, RTE001 had an overall percent positive rate of 0.39 and a 0.49 percent positive rate for
the sliced, diced, and shredded product category. Because of the change in product categories implemented in November 2009, the CY 2009
product categories results cannot be compared with results from previous years. The ALLRTE had a 0.25 percent positive rate across all
product categories (7 positives in 2,761 samples analyzed), and the RTE001 had a 0.43 percent positive rate (35 positives in 8,158
samples analyzed), across all product categories.
As noted above, the 10 product categories were based on factors that relate to the effectiveness of the kill step. The Salmonella
results for RTE products do not indicate any differences related to the effectiveness of lethality. FSIS testing has consistently found very
low levels of Salmonella in RTE products. While the percentage of samples positive for Salmonella in CY 2006 had been the lowest level
since the implementation of HACCP (2 positives in 11,842 samples), FSIS found 10 positives in 11,651 samples for CY 2007 (0.09 percent),
the highest percentage since 2002. In CY 2008, the 12,041 RTE samples analyzed for Salmonella in both the ALLRTE and RTE001 sampling programs
(Table 21) identified five positive samples (0.04 percent positive). The 3,120
samples analyzed for the ALLRTE sampling program resulted in a 0.13 percent positive (4 positives in 3,120 samples). In the RTE001 sampling
program, the percent positive rate was 0.01 percent (1 positive in 8,921 samples analyzed). In CY 2009, ALLRTE and RTE001 sampling programs
identified four Salmonella positive samples in the 10,918 samples analyzed (0.04 percent positive)
(Table 23). FSIS analyzed 2,761 samples for Salmonella in the ALLRTE sampling project,
with one positive result observed (0.04 percent positive). FSIS analyzed 8,158 samples in the RTE001 sampling project, with three positive
samples observed (0.04 percent positive).
The Agency has also tested RTE products for E. coli O157:H7 and staphylococcal enterotoxins. From 1994 through 2007, FSIS tested
8,830 RTE products (cooked beef patties and dry fermented sausages) for the presence of E. coli O157:H7 (excluding imported products).
In 2008, FSIS tested 548 RTE products (158 for the ALLRTE and 390 for the RTE001 sampling programs respectively) for E. coli
O157:H7. In CY 2009, FSIS tested 510 RTE product samples (138 and 372 for the ALLRTE and RTE001 sampling programs respectively) for
E. coli O157:H7, and the Agency tested 590 RTE products (176 for the ALLRTE and 414 for the RTE001 sampling programs respectively)
in 2010. All RTE samples tested for E. coli O157:H7 have been negative. Between 1994 and December 2002, FSIS tested 3,105
RTE products for the presence of staphylococcal enterotoxins, and all tests were negative. FSIS discontinued testing of RTE products for
staphylococcal enterotoxins in January 2003.
Index of Tables & Figures |
Results From Previous Years
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Contact Information:
Food Safety and Inspection Service
Office of Public Health Science
Microbiology Division
Nisha Oatman Antoine, MPH
Phone: (202) 690-6369
FAX: (202) 690-6364
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| Last Modified:
August 1, 2011 |
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