Daily Rules, Proposed Rules, and Notices of the Federal Government
FSIS administers a regulatory program under the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601
Since the late 1980s, FSIS has been sampling RTE meat and poultry products for the pathogen
The RLm sampling program is a risk-based program designed to detect
Under another risk-based program, IVT, inspectors (or EIAOs) collect follow-up samples if RTE meat or poultry product samples or food-contact surface samples test positive for
When conducting sampling of post-lethality-exposed RTE product for
From the 1-lb RLMPROD or INTPROD sample it receives, the laboratory draws a 25-g unit which it analyzes according to procedures in the FSIS Microbiology Laboratory Guidebook (MLG) (
Currently, a sampling unit for both RLm and IVT sampling programs consists of 10 food-contact surface, five non-food-contact environmental surface, and three food product samples. FSIS is not making any changes to its food-contact and non-food contact surface sample testing.
FSIS is planning, however, to change the number of food product samples per sampling unit it collects when sampling for
To support an increase in the sample size analyzed (from 3 × 25 g, or 75 g per sampling unit, to 5 × 25 g, a total of 125 g per sampling unit), FSIS performed a validation study of the current FSIS
FSIS is initiating these changes to its procedures to make the results of its analyses more comparable with results obtained internationally. Many countries are following the Codex Alimentarius Commission
FSIS is also initiating these changes to its procedures to conserve laboratory resources. While FSIS will be collecting more product samples, FSIS expects that compositing five 25-g RLMPROD samples into a single 125-g test portion will reduce the overall number of analyses performed and thus reduce the associated laboratory costs.
Furthermore, FSIS expects that increasing the number of product samples and test portions per sample will have a positive impact on public health because implementing these changes increases the potential for detecting positive samples. For example, from July 2010 to June 2012, with three samples per sampling unit, FSIS tested around 460 INTPROD samples per year. Of those samples, approximately five samples (about one percent of tested samples) were found to be positive for
If the Agency had increased the number of RLMPROD product samples from three to five per sampling unit but did not decide to composite these samples, there would have been increased costs to FSIS. Agency data shows that the annual number of product samples analyzed is 1,882 for RLMPROD and 432 for INTPROD.
The Agency has estimated the savings to the laboratories by reducing the number of sample analyses performed to be approximately $40,000, which includes savings for expendable supplies such as gloves, plates, etc.
One major cost to the industry will be the likely loss from the additional contaminated RTE products detected by the additional sampling, which the establishments will have to destroy. Even though these adulterated products should be destroyed and not sold to consumers, establishments would have earned revenue selling these products. If additional testing results in more positive samples, more product will need to be discarded and, in turn, yield less revenue for the establishments.
The Agency used the most recent data on the average price of deli meats compiled by FreshLook Marketing Group as a proxy for the price of RTE meat and poultry products, which is $6.98 per pound.
(2) Total U.S. traditional grocery store scanner data. Deli meats include deli beef/pork/bacon, bologna, frankfurter, ham, loaves, poultry, salami, sausage, specialty meats/pates, and other. Price is 52-week average as of 6/19/2011.
(3) Most contaminated RTE samples are from deli meats and hotdogs. Therefore, this price index is a reasonable proxy.
If establishments that are already testing for
The main benefit from increasing the sample number is the reduction of illnesses and deaths caused by
According to the most recent CDC analysis, there are about 1,591 (with a range of 557 to 3,161) domestically-acquired foodborne illnesses caused by
The Agency's analysis suggests that the new sampling will reduce the number of illnesses by an average of 90 cases per year (with a range of 3 to 134).
The Agency also expects that with the increased sampling, the establishments will strengthen their own
As explained in the Expected Costs and Expected Benefits Sections, there are uncertainties in the Agency's cost and benefit estimates. Consequently, it is very difficult to arrive at a concrete estimate of net benefits. The biggest uncertainty is that FSIS cannot accurately predict the amount of adulterated product that will be detected as a result of increasing the sampling numbers. The Agency can only estimate the amount with some strong assumptions. The Agency believes that it can have a reasonable net benefit estimate by adding the estimated benefits from reduced illnesses ($117 million), then subtracting the cost to the industry ($58.6 million). The result is a net benefit of about $58.33 million annually.
The changes in FSIS's sampling procedures do not impose a testing requirement on official establishments. Therefore, these changes will not have a negative effect on small or very small establishments.
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