Daily Rules, Proposed Rules, and Notices of the Federal Government
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In 1994, FSIS determined that
Starting in 2007, FSIS began testing beef manufacturing trimmings and other raw ground beef components (raw esophagus (weasand) meat, head meat, cheek meat, beef from advanced meat recovery systems, low temperature rendered lean finely textured beef, partially defatted chopped beef, partially defatted beef fatty tissue, and heart meat) for
FSIS sampled beef manufacturing trimmings under a simple random sampling plan in which each slaughter establishment had an equal chance of being scheduled for sampling, regardless of production volume or previous history. FSIS collects approximately 1,300 samples per year. From calendar year 2007 through June 2011, FSIS found an average of about seven
Inspection personnel collect beef trimmings samples for testing using N-60 procedures. Under these procedures, inspection personnel collect 60 slices of beef manufacturing trimmings cut to a specific size and also collect an additional, separate “grab sample” of smaller pieces of trim from the same production lot. FSIS laboratories use the 60 slices for the first part of the analysis for
When an FSIS beef manufacturing trimming sample tests positive, FSIS takes a number of steps including: Collecting follow-up samples at the establishment where the positive sample was found; documenting production of adulterated product in a noncompliance record when appropriate; conducting a food safety assessment (FSA) (a comprehensive review of the establishment's food safety
OIG audited the efficacy of FSIS testing for
(1) Develop a plan to perform baseline studies of beef manufacturing trimmings and ground beef to determine the estimated prevalence rate of
(2) Re-evaluate sample parameters (size and confidence level) to provide a higher confidence level for FSIS' ability to detect contaminated product and to more effectively verify process controls at beef slaughter establishments.
(3) Document the scientific support and rationale for the revised verification testing program design, including the contamination level that will be associated with the new sample parameters, and how the estimated prevalence rate has informed the redesigned verification testing program. Publish in the
In response to the first recommendation, FSIS plans to make changes in its
In 2013, FSIS intends to initiate a beef carcass baseline survey to determine the presence and levels of the pathogenic
As the Agency has done with previous baseline surveys, FSIS will report the results of this survey on its Web site and incorporate them into compliance guidance for industry to use in assessing individual establishment performance against the national performance. Controls to reduce the risk of enteric pathogen contamination at slaughter are crucial. Under 9 CFR 310.18(a), establishments must handle beef carcasses, organs, and other parts in a sanitary manner to prevent contamination with fecal material, urine, bile, hair, dirt, or foreign matter. Because these sources of contamination, whether visible or not, may contain pathogens, a principal objective of proper sanitary dressing and process control procedures is to reduce the potential for exposure of carcasses and parts to any contamination or food safety hazard during the removal of the hide, feet, head, gastrointestinal tract, and other internal organs. If establishments implement effective controls during sanitary dressing procedures, it is likely that it will prevent or reduce contamination significantly. This survey will be important to the Agency in assessing the prevalence of the load of pathogens and certain indicator organisms on carcasses throughout the slaughter process. In addition to informing the future Agency compliance guidance, FSIS will also use the baseline survey results to make changes to its sampling, testing, and other verification activities.
In response to OIG recommendation #2, FSIS decided to revise the N-60 program to provide for more frequent sampling at establishments that the Agency determines have problems controlling
FSIS also found that the percent-positive rate in the high-prevalence season (now considered to be May through October, rather than April through September, on the basis of FSIS data) is about 2 times as high as it is the rest of the year. Accordingly, the analysis concluded that increasing the sampling of beef manufacturing trimmings during May through October should increase the probability of detecting
FSIS determined that there are about 480 slaughter establishments in the beef manufacturing trimmings sampling frame that are eligible for sampling. FSIS selects between 200 and 250 establishments from the frame every month for sampling. Annually, FSIS
Based upon the results of its analysis, FSIS has already redesigned its
FSIS will take measures to increase the number of samples that the Agency successfully collects. As stated above, FSIS has already increased the time during which field personnel may collect a sample from 30 days to 60 days. This increase allows field personnel additional time to collect samples for testing in establishments that infrequently produce manufacturing trimmings. FSIS also plans to over-schedule the sampling to increase the total number of samples actually collected. On the basis of the changes FSIS has made to its N-60 program to date, FSIS estimates that the probability of obtaining
FSIS does not plan to increase the annual statistical sample size but will redistribute the samples on the basis of an analysis of the Agency's sampling program for beef manufacturing trimmings. The changes to the sampling program, however, may increase the number of follow-up samples collected as a consequence of finding more
In its response to OIG, FSIS suggested that sanitary dressing noncompliances may be related to
In November 2011, FSIS revised its sanitary dressing verification directive (FSIS Directive 6410.1) to improve and clarify for FSIS inspectors the procedures that they are to follow in verifying sanitary dressing compliance. This revision and the expected improvement in inspector verification of sanitary dressing procedures may result in a higher correlation between sanitary dressing noncompliances and
As is discussed above, in responding to an Agency
OIG recommended that FSIS re-evaluate sample parameters (size and confidence level). Sample size calculations were not performed as part of the statistical assessment in order to stay resource neutral. FSIS intends to evaluate the allocation of sampling resources within the
Additionally, FSIS intends to better identify establishments likely to have problems with
As the Agency announced in the September 11, 2011, notice on non-O157 STEC (76 FR 58157), FSIS is also planning to conduct a survey, using its employees that are assigned to beef slaughter and processing establishments, to gather information on establishment controls for STECs in beef. This survey will be similar to a previous “65-07 Checklist” survey.
OIG recommended, and FSIS considered, the use of specialized
In a more recent audit, reported in May 2012, OIG studied the variation of the beef industry's
OIG made several additional recommendations to FSIS, and the Agency has already responded to some of them. For example, OIG recommended that FSIS issue guidance for industry on sampling and how the industry might plan for and react to high-event periods (HEPs)—when slaughter establishments have a high rate of positive test results for
On May 7, 2012, FSIS announced the availability of compliance guidance for establishment sampling and testing for Shiga toxin-producing
During an HEP, adulteration may be more widespread than a positive-testing lot of product may indicate. By following the guidance and withholding adulterated product from commerce during HEPs, establishments are more likely to avoid costly recalls. While establishments can use the guidance now, FSIS requested comments on it and will update it as necessary in response to the comments.
OIG also recommended that FSIS re-evaluate and improve its policies on inspector collection of trim samples by, for example, ensuring that inspectors randomly select product for sampling, ensuring that inspectors collect samples of proper weight, and ensuring that they do not take multiple samples from single pieces of trim.
To ensure that all raw ground beef, beef manufacturing trimmings, and bench trim samples are the necessary weight, FSIS recently issued instructions to inspection program personnel on the use of new sample collection bags that have fill-lines.
OIG recommended that FSIS improve communication with industry by issuing guidance to assist establishments in selecting laboratories according to the laboratories' testing capabilities. On March 8, 2012, FSIS announced the availability of guidance for establishments in the selection of commercial and private microbiological testing laboratories (77 FR 13999). The guidance includes a checklist for industry on the issues to consider and also the types of documents that establishments should maintain to support their testing programs.
OIG further recommended that FSIS determine whether to increase sampling of trim, assess its performance measures for
FSIS will announce this notice online through the FSIS Web page located at:
FSIS will also make copies of this
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