The Food Safety and Inspection Service (FSIS) issued the Pathogen Reduction; Hazard Analysis and Critical Control Point (HACCP) Systems; Final Rule on July 25, 1996: Federal Register, Vol. 61, No. 144, pp. 38805-38989. To verify that industry Pathogen Reduction/HACCP (PR/HACCP) systems are effective in controlling the contamination of raw meat and poultry products with disease-causing bacteria, the PR/HACCP rule sets Salmonella performance standards that slaughter establishments and establishments that produce raw ground products should meet. These product-specific limits on Salmonella became effective in large establishments on January 26, 1998, in small establishments on January 25, 1999, and in very small establishments on January 25, 2000. FSIS verifies that establishments are meeting the standards by having federal inspection personnel collect randomly selected product samples and send them to FSIS laboratories for Salmonella analysis, according to procedures described in Appendix E of the PR/HACCP final rule: Federal Register, Vol. 61, No. 144, pp. 38917-38928 (http://www.fsis.usda.gov/OA/fr/haccp_rule.htm).

The Salmonella performance standards are based on the prevalence of Salmonella as determined from the agency's nationwide microbiological baseline studies (http://www.fsis.usda.gov/Science/Baseline Data/) conducted before PR/HACCP was implemented. Raw products currently covered by performance standards are carcasses of cows/bulls, steers/heifers, market hogs, and broilers, and ground beef, ground chicken, and ground turkey. The performance standards are expressed in terms of the maximum number of Salmonella-positive samples that are allowed per sample set. The number of samples in a sample set varies by product, and the maximum number of positive samples allowed in a set provides an 80% probability of an establishment passing when it is operating at the standard.

There are two phases of the FSIS regulatory program for Salmonella in raw products: non-targeted and targeted testing. Any initial set or any set that follows a passed set is part of the "on-going" or non-targeted testing program. These sets have been designated as "A" sets. Other codes (such as "B", "C", and "D") represent sample sets collected from establishments that are targeted for follow-up testing following a failed set. Non-targeted or "A" sets are collected at establishments randomly selected from the population of eligible establishments that are not currently in the targeted phase of the program, with a goal of scheduling every eligible establishment at least once a year. The scheduling for targeted testing is based on inspection program guidance provided in Chapter 3 of FSIS Directive 5000.1. In establishments producing multiple raw products, FSIS may collect samples from any or all products subject to the performance standard (9 CFR parts 310.25 (b)(2) and 381.94 (b)(2)), so a single establishment may be represented in multiple product class categories.

The data reported here are from the non-targeted regulatory testing program, i.e., results from the code "A" samples. The Agency recognizes that some establishments having the most difficulty in controlling Salmonella can be in the targeted testing for an entire year, and are, therefore, not subject to non-targeted testing during that year. Nevertheless, in the absence of continuous baseline studies, the Agency considers the "A" set data to be the best set of data to indicate trends. The regulatory test results are also compared to the performance standards which were based on baseline estimates of national Salmonella prevalence determined prior to the implementation of PR/HACCP.

FSIS uses data from its regulatory testing program primarily to monitor the effectiveness of HACCP programs in individual establishments. The regulatory testing program was not designed to address specific hypotheses related to change in national product prevalence. Variation among parameters known to affect Salmonella contamination (collection season, establishment location) may confound comparisons by year or establishment size. Still, regulatory testing can yield useful data on time- and industry-related trends for Salmonella following the implementation of PR/HACCP.

In this report, the data from the non-targeted Salmonella testing ("A" sets) for both individual samples and establishment sets are presented by year for the period 2001 - 2004, and in aggregated form for the period 1998 - 2000 (Table A1 and Table A2). The percent of positive tests in groups stratified by product class and sample year are presented as a percent of the baseline prevalence in Figure A1, and the percentage of sets meeting the performance standard in groups stratified by product class and calendar year are plotted in Figure A2.

The Salmonella results for individual samples (Table A1 and Figure A1) represent samples collected during the calendar year (January 1 to December 31, 2004). Because Salmonella test sets (Table A2 and Figure A2) may extend over a period of weeks or months, set data are reported by the year in which the final sample was collected.

Establishment size information is based on the size status at the end of the calendar year. Beginning with the CY 2002 data, the Agency added a column for "size unknown" because there continued to be a small amount of data that could not be categorized by establishment size. Prior to CY 2002, data for establishments not providing production size information was included in the "very small" category. All CY 2004 data was categorized by establishment size.

In 2004, the percent of positive Salmonella tests among samples from non-targeted establishments stratified by product class and establishment size ranged from 0 to 29%. The highest positive rates¹ were noted among poultry products (broiler carcasses, ground chicken and ground turkey) in large, small, and very small establishments. For CY 2004, the percentage of positive "A" set samples decreased for all three beef categories. The non-targeted testing program did not find a single positive in 1,993 beef carcass samples (both steer/heifer and cow/bull) from large establishments. In CY 2004, the percentage of positive samples for market hogs increased from the CY 2003 level of 2.5% up to 3.1% after four consecutive years of declining levels.

¹Defined as greater than or equal to the 75th percentile of percent positive tests for all product/establishment size combinations in 2004.

For all combinations of product class and establishment size, the percentage of CY 2004 samples positive for Salmonella was lower than the baseline prevalence established prior to PR/HACCP implementation. When stratified by product class alone, Salmonella positive rates from non-targeted regulatory testing have never exceeded the product class specific baseline estimate over the period 1998 - 2004 with the exception of market hogs in CY 1999 (Figure A1).

Of 1,004 "A" sets completed in CY 2004, 956 (95.2%) met the product-specific performance standard. Compliance with product-specific performance standards ranged from 77.8% - 100% when the data was stratified by product class and establishment size.

When FSIS reported the 2003 data, the Agency acknowledged concern that the percentage of positive Salmonella tests had increased slightly in all three poultry categories. While the 2004 data show more mixed results, there was a continued increase for young chicken (or broiler) carcasses. FSIS has increased the resources being allocated to comprehensive Food Safety Assessments in establishments displaying negative performance trends and is now considering how best to integrate past performance into the Salmonella testing program.

The Agency analyzed a total of 54,750 non-targeted samples in CY 2004 for the seven product categories. Of these, 2,052 (3.7%) were positive. When the results were weighted to account for variations in sampling across product categories, there was not an overall decrease in the percentage of positive samples for CY 2004. This was the first year since HACCP implementation that there had not been an overall decrease in the percentage of positive samples when results are weighted by the proportion of samples collected for each category in 2001.

The presence of Salmonella in raw meat and poultry products at the time of inspection is just one factor contributing to the incidence of foodborne salmonellosis. Important strides toward the elimination of this pathogen will be realized when effective interventions are applied to all segments of the food production and distribution chain, including animal and plant husbandry, production, transportation, and preparation.

Achieving a reduction in pathogens reduces the risk of illness. However, all segments of the food-production chain and consumers should continue to properly handle, cook, and store all meat, poultry, and other food products in order to guard against foodborne disease.

For More Information:

• Media - (202) 720-9113
• Congressional - (202) 720-3897
• Constituent - (202) 720-9113
• Consumer inquiries - Call USDA's Meat and Poultry Hotline at 1-888-MPHotline (1-888-674-6854). The TTY number is 1-800-256-7072.
• Technical inquiries - Director, Microbiology Division, Office of Public Health Science, (202) 690-6369
• FSIS Web Site: http://www.fsis.usda.gov