Posted: May 22nd, 2012 - 5:23pm
Source: USDA

Executive Summary
On November 12, 2009, the Chairwoman of the House Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies wrote to the United States Department of Agriculture’s (USDA) Office of Inspector General (OIG) to express concerns about the efficacy of the testing the Food Safety Inspection Service (FSIS) performs to detect Escherichia coli O157:H7 (E. coli) in U.S. beef “trim.”
In order to respond to this Congressional request, OIG divided its work into two phases. In Phase 1, which we completed in February 2011, we reported that FSIS’ current method of sampling beef for E. coli—known as N-60—does not yield the precision reasonable for food safety purposes, and recommended that FSIS thoroughly reevaluate its sampling program for testing beef in order to effectively verify process controls at beef processing plants.
In this report, we are presenting the results of Phase 2 of our review, which is based on fieldwork at beef slaughter and processing plants. OIG initiated this portion of our audit to analyze whether the beef industry’s sampling and testing protocols vary among plants and differ from FSIS standards, and also to examine whether test results are used by FSIS and the beef industry to improve food safety.
Based on our visits to six beef slaughter plants—directly responsible for processing about 17 percent of the U.S. beef supply—we found that industry was performing thousands of E. coli tests daily generally following FSIS’ recommended procedures. Overall, industry was taking appropriate steps to help ensure that U.S. beef is safe from E. coli contamination, recognizing that regardless of how stringently the industry tests for E. coli, there is always an inherent risk of its presence in slaughter plants. We found these large plants showed strong initiative in their efforts to control contamination and limit the ability of adulterated meat to make its way in to commerce. Plants took preemptive action, often acting on presumptive positive test results and in some instances, destroying whole days’ worth of production in the name of safety. When positive test results were found, plants were conducting investigations to determine the cause and applied corrective actions to prevent future occurrence of E. coli contamination. We also found that these plants generally utilized nationally accredited laboratories for their sample analysis.
We did, however, note several areas where FSIS and industry could further ensure food safety.
Since consumers ultimately rely on industry’s testing and interventions to keep our beef E. coli free, it is critically important that, when plants receive multiple positive test results (otherwise known as “high event” periods), the plants respond appropriately to these spikes in E. coli contamination. We found, however, that FSIS has not issued detailed and sufficient guidance for defining industry’s plans for high event days and setting forth the agency’s expectations for how industry should react. Predictably, different plants have very different high event day plans with different critical elements. By providing better guidance to plants about how they should develop their plans, and what critical elements should be included, FSIS can also make the process more transparent to industry. In this way, FSIS and industry may also avoid a situation like the one that took place in September 2011, when a plant shipped about 80,000 pounds of beef after it received multiple positive E. coli tests during its production. After an FSIS investigation, the plant recalled this beef. OIG maintains that, if FSIS is more explicit about how it expects plants to respond to such high event days, the agency, industry, and the public will benefit.
We also found that FSIS needs to consider shifting more of its testing resources to sampling trim, instead of ground beef, for E. coli. At present, each year FSIS collects and tests many more samples of raw ground beef than trim (about 12,300 compared to 1,270 in 2011) even though data strongly indicate that positives are more likely to be found in trim than raw ground beef.
This has occurred because FSIS initially focused its efforts on finished ground beef, and it was not until 2007 that FSIS began testing trim. More recently, however, USDA has begun to emphasize the testing of trim, particularly in testing for other types of pathogens, such as the recent initiative to begin testing for six additional strains of E. coli other than O157:H7. OIG believes that FSIS should follow suit and begin testing more trim so that it can maximize its results, better promote public health, and trace contamination problems to their source.
FSIS also needs to improve the consistency with which its inspectors collect N-60 samples since we found that, although inspectors are required to take samples that weigh about 325 grams, they often took samples that were much too large. Dealing with these overweight samples taxes the laboratory’s resources and dilutes the ratio of surface to interior tissue—the exterior is where E. coli contamination is most likely to be found. Inconsistencies of this sort occur because FSIS has not adequately evaluated how inspectors perform their work to identify and address these types of problems. If FSIS does not sample consistently, then N-60 may not be serving its intended purpose of verifying that plants’ E. coli-preventing interventions are working as intended and that FSIS is effectively monitoring the plants’ operations.
We also noted that in some cases FSIS’ sampling policies and procedures allowed plants to
sidestep regulations to avoid receiving noncompliance records. FSIS needs to eliminate these policy ambiguities because noncompliance records trigger more serious enforcement actions and require corrective measures that would improve how the plants control E. coli.
Finally, we found that FSIS needs to take steps to ensure that small plants, particularly those regulated by State meat inspection agencies as part of a cooperative agreement with USDA, are being correctly overseen. Although Talmadge-Aiken (T/A) plants (known by the common name of the law that created this arrangement), are responsible for less than 1 percent of the U.S. beef supply, our visit to one of these plants in Utah indicated that the State agency was not issuing the plant noncompliances for serious deficiencies in the plant’s sanitary dressing procedures. These problems occurred because FSIS was not effectively communicating its standards and guidance and was conducting only sporadic oversight of the State agencies. FSIS officials stated that they were unaware of these problems and the agency intends to perform their own internal review to determine if T/A plants warrant increased oversight.
OIG concluded that, overall, industry was taking adequate steps to ensure that beef leaving slaughter plants is free of E. coli contamination, but that FSIS could take additional steps to strengthen certain elements of the E. coli sampling and testing system.
Recommendation Summary
Issue revised guidance to industry regarding the agency’s expectations for trim sampling and how industry should plan for and react to high event day periods, including the critical elements to be included in a high event period plan and the necessary support for the high event period criteria.
Review the available scientific data and hold discussions with appropriate stakeholders to determine if FSIS sampling resources could be better utilized and if the identification of E. coli contamination could be improved by sampling more beef trim and less ground beef.
Reevaluate the policies for how inspectors collect trim samples, including collecting samples of proper weight. Also reevaluate noncompliance policy ambiguities and revise agency procedures to ensure that industry is not avoiding regulatory action.
Develop a detailed plan with milestones and timeframes to determine whether the quality of inspection in T/A plants is such that there is a higher potential for E. coli contamination in the products these plants produce. If so, require additional FSIS oversight and improve communication at T/A plants and State inspection agencies.
Agency Response
In its April 13, 2012, written response to the official draft report, FSIS expressed agreement with all our findings and recommendations. We have incorporated the FSIS response in the Findings and Recommendations section of this report, along with our comments in the applicable OIG Position sections. FSIS’ response to the official draft is included in its entirety at the end of this report.
OIG Position
We concur with FSIS’ proposed corrective actions and have accepted management decision for all seven recommendations. We have provided our comments on each recommendation in the applicable OIG Position sections.