| Food Safety and Inspection Service United States Department of Agriculture Washington, D.C. 20250-3700 |
FSIS Draft: February 26, 1999
Questions and Answers on Beef Products Contaminated With E. coli O157:H7
DRAFT
- THE FOLLOWING QUESTIONS AND ANSWERS REFLECT THE CURRENT THINKING OF FSIS REGARDING ITS POLICIES DISCUSSED IN THE RECENT FEDERAL REGISTER NOTICE ON E. coli O157:H7 64 FR 2803, Beef Products Contaminated with Escherichia coli O157:H7, January 19, 1999).
- THESE QUESTIONS AND ANSWERS WERE DEVELOPED TO GENERATE DISCUSSION AT THE UPCOMING PUBLIC MEETING (March 8, 1999) ON THIS SUBJECT.
- FSIS WELCOMES COMMENTS AT THE PUBLIC MEETING ON OTHER RELEVANT ISSUES NOT DIRECTLY ADDRESSED BY THE QUESTIONS AND ANSWERS RAISED IN THIS DOCUMENT.
- FSIS INVITES THE PUBLIC TO SUBMIT WRITTEN COMMENTS AND RECOMMENDATIONS RELEVANT TO THE FSIS POLICY, AND ANY REGULATORY REQUIREMENTS THAT MAY BE APPROPRIATE TO PREVENT THE DISTRIBUTION OF BEEF PRODUCTS ADULTERATED WITH THIS PATHOGEN. 1
- FSIS WILL PROVIDE FURTHER GUIDANCE TO THE PUBLIC, AS APPROPRIATE, BASED UPON INFORMATION RECEIVED AT THE PUBLIC MEETING, IN WRITTEN COMMENTS, AND FROM OTHER RELEVANT DOCUMENTS.
- FSIS ENCOURAGES ALL ESTABLISHMENTS TO ADDRESS THE HAZARD POSED BY E. coli O157:H7 AS A PART OF A HACCP SYSTEM.
1Submit one original and two copies of written comments to FSIS Docket Clerk, Docket No. 97-068N, USDA, FSIS, Room 102, Cotton Annex Building, 300 12th Street, S. W., Washington, DC 20250-3700. All comments submitted in response to Docket No. 97-068N will be available for public inspection in the Docket Clerk's Office between 8:30 a.m. to 4:30 p.m., Monday through Friday, except for Federal holidays.
Question 1: What quantity of a beef product, other than a raw ground beef product, does FSIS consider contaminated if a sample of the product tested by a receiving establishment is found to be contaminated with E. coli O157:H7?
Answer: A receiving establishment's testing protocol (i.e., the design of the sampling program, which typically contains information such as sample selection criteria, sample size, and frequency of sampling) should, among other things, specify the product units (e.g., combos, boxes, or other containers of product, or carcasses) that a sample is designed to represent.2 The E. coli O157:H7 status of product units, maintained separately to prevent cross-contamination at all times by the receiving establishment, should be determined by sampling either an individual product unit or an appropriate number of randomly selected product units to represent the total number of product units (i.e., the establishment's pre-determined lot). In some instances, the establishment may choose to sub-divide the lot into sublots whereby each sublot has a pre-determined number of product units assigned to it. In such instances, one or more product units may be sampled (i.e., a small amount of product is removed from the selected product units within the sublot and combined to result in one composited sample) to represent the total number of product units in the sublot. Only the product units that are represented by the positive sample will be considered contaminated.
For practical purposes, at this time, when a sample of beef, other than raw ground beef, is determined to be positive for E. coli O157:H7 at a receiving establishment, FSIS will not consider other beef manufactured during the same shift or from the same source materials at the supplying establishment that a positive sample was not designed to represent to be contaminated with E. coli O157:H7.
2 FSIS is encouraging supplying and receiving establishments to begin a dialog with FSIS about their testing protocols for carcasses, carcass parts, and manufacturing trimmings so that further guidance on testing protocols can be made available, especially to small and very small establishments.
Question 2: What is an appropriate testing protocol for manufacturing trimmings in order to determine their E. coli O157:H7 status?
Answer: Although an establishment, not FSIS, is responsible for determining both the design and the adequacy of its testing protocol, FSIS is making the following recommendations regarding features of an appropriate protocol. The protocol should include the selection of multiple sub-samples (e.g., five or more pieces or defined units weighing a few ounces to a few pounds) from the smallest possible segregated amount of beef (e.g., one or more combos of manufacturing trimmings). In addition, it should provide that the sub-samples be selected from multiple areas within the segregated product unit. An example of an appropriate protocol might include, at a minimum, the analysis of 325 grams of product per lot, sublot, or individual product unit. The establishment should randomly select five 65-gram sub-samples (for a total of at least 325 grams), created from as many separate meat pieces as possible with the maximum amount of exposed surface. Efforts should be made to select meat pieces to be representative of the entire product unit being sampled. If necessary, the establishment should aseptically cut meat pieces to obtain manageable sizes or to ensure a representative sampling. The establishment should analyze each 65-gram sample separately, or a larger composite if desired. However, the laboratory methodology should be capable of detecting one colony forming unit of the pathogen in the total individual sample size (in grams) being tested.
Question 3: If a receiving establishment samples two of ten combos of manufacturing trimmings that were purchased from the same supplier, and then determines that one of the samples is positive for E. coli O157:H7, is all of the product in the ten combos considered contaminated with E. coli O157:H7?
Answer: Before collecting the samples, the receiving establishment should have had a testing protocol that specified the combos that the samples were designed to represent. If the testing protocol specified that each sample only represented the combo from which the sample was drawn, then the product in only the combo represented by the positive result would be considered contaminated with E. coli O157:H7. The product in the combo represented by the sample with a negative result would not be considered contaminated and can be used as source material for raw ground beef product. [NOTE: Microbiological testing can provide only a limited measure of assurance that product is not contaminated with E. coli O157:H7 because this pathogen is distributed sporadically in beef and at extremely low levels. Therefore, the fact that a sample from one combo tested positive may or may not mean that the probability of a positive result in common source materials is higher than the probability of finding a positive at random. FSIS is interested in receiving data on such questions as the probability that the product represented by the negative test result described in this situation is, in fact, not contaminated. Alternatively, would it be advisable for the receiving establishment to test additional sample units (i.e., conduct rigorous sampling and testing) of such product (to increase the chances of finding E. coli O157:H7, if present) before using it in ground beef products? Or, should the receiving establishment view this as "potentially higher risk" product and divert it to processing into large mass raw product (e.g., raw meat loaf mixture, which is generally adequately cooked before consumption)3 or ready-to-eat (RTE) product?]
Going back to the original question, if the testing protocol specified that the two samples represented all ten combos, then all of the product in the ten combos should be considered contaminated with E. coli O157:H7 since one of the two samples that represented the combos was positive. However, if the testing protocol addressed only the two sampled combos and did not address the remaining eight combos, the two sampled combos should be handled according to the testing protocol. In addition, the remaining eight combos should be sampled and tested in order to determine if E. coli O157:H7 is present.
3 See "Guidance for Beef Grinders to Better Protect Public Health." Single copies of the revised guidance document (December 1998) are available from the FSIS Docket Clerk in room 102, Cotton Annex Building, 300 12th Street, S. W., Washington, DC 20250-3700 from 8:30 a.m. to 4:30 p.m., Monday through Friday, except for Federal holidays. In addition, an electronic version of the guidance document is available on line through the FSIS web page located at http://www.fsis.usda.gov.
Question 4: If a receiving establishment samples one of ten combos of manufacturing trimmings that were purchased from the same supplier, mixes trimmings from the sampled combo with trimmings from the remaining combos, and then determines that the sample is positive for E. coli O157:H7, is all the product considered contaminated?
Answer: Yes. In this situation, the identity of the trimmings (i.e., the defined quantity of meat segregated and stored in separate containers to prevent cross-contamination) has not been maintained.
Question 5: What traceback or other action will FSIS pursue with respect to a supplying establishment whose beef is found to be positive for E. coli O157:H7 by a receiving establishment?
Answer: FSIS does not intend to attempt to traceback the product to, or to take any regulatory action against, a supplying establishment that shipped E. coli O157:H7 contaminated product, unless there is reason to believe that the supplying establishment knew that the product was contaminated with E. coli O157:H7 and did not have in place and follow the controls necessary to prevent adulterated product from being distributed to consumers.
Question 6: What action should be taken by a supplying establishment when its beef is found to be positive for E. coli O157:H7 by a receiving establishment?
Answer: Appropriate action would include the following: 1) Reviewing the adequacy of its testing protocol; 2) performing appropriate corrective action before reassessing its HACCP plan (including pathogen reduction interventions), especially regarding E. coli O157:H7 contamination, or implementing a HACCP system as soon as possible; 3) conducting rigorous sampling and testing of the source materials (i.e., other beef manufactured on the same day and on the same production line), if still available; 4) reviewing its documentation to ensure that procedures are in place for identifying the distribution channels for other beef from the same source materials; and 5) informing other receivers of the same source materials about the positive finding, especially receivers who manufacture raw non-intact products.
Question 7: What action should a receiving establishment take if manufacturing trimmings at the receiving establishment are found to be positive for E. coli O157:H7?
Answer: Appropriate action would include the following: 1) Performing appropriate corrective action before reassessing its HACCP plan, especially regarding E. coli O157:H7 contamination, or implementing a HACCP system as soon as possible; 2) ensuring that the product is processed into RTE product; 3) rejecting the product and returning it to the supplying establishment; 4) destroying the product for human consumption; 5) diverting the product from human food channels (e.g., designating it for further processing as pet food); or 6) requesting condemnation of the product by FSIS. Regardless of the action taken, the receiving establishment should notify the supplying establishment of the positive E. coli O157:H7 finding. In addition, the receiving establishment should thoroughly document the actions it takes regarding this product.
Question 8: What action should a receiving establishment take if it is informed that product it has received was manufactured from the same source materials as other product that has tested positive for E. coli O157:H7?
Answer: Appropriate action would include the following: 1) Performing appropriate corrective action before reassessing its HACCP plan, especially regarding E. coli O157:H7 contamination, or implementing a HACCP system as soon as possible; 2) reviewing the adequacy of its testing protocol; 3) conducting rigorous sampling and testing of the product, if still available; and 4) using the product either for raw ground beef product or for processing into large mass raw product or RTE product. In addition, the receiving establishment should thoroughly document the actions it takes regarding this product.
Question 9: Does FSIS require special shipment control between official establishments regarding product that has tested positive for E. coli O157:H7?
Answer: At this time, FSIS does not have specific regulations regarding the control and handling of product that has tested positive for E. coli O157:H7. FSIS does have general procedures for handling the movement of product between official establishments (e.g., to return rejected product from a receiving establishment to a supplying establishment, or to transport product from one establishment to another for cooking).
FSIS is aware that the procedures for controlling the movement of product for further processing, especially E. coli O157:H7 contaminated beef, may need to be clarified, as well as more specifically regulated. Recently, FSIS recommended, through its revised document "Guidance for Beef Grinders to Better Protect Public Health," that ground beef manufacturers without facilities for processing RTE products should identify outlets for further processing. In the January 19 Federal Register Notice on E. coli O157:H7, FSIS specifically asked for comments and recommendations on any regulatory requirements that may be appropriate to prevent the distribution of beef products adulterated with E. coli O157:H7. Meanwhile, FSIS does intend to clarify its instructions to inspection program personnel regarding procedures for verifying that establishments have properly handled E. coli O157:H7 positive product.
Question 10: Will the January 19 Notice on E. coli O157:H7 change the products currently tested by FSIS for this pathogen (see FSIS Directive 10,010.1 4)?
Answer: No. FSIS does not intend at this time to change the products it currently samples. The FSIS testing program addresses samples of raw comminuted (chopped or ground) meat food products made from cattle carcasses (beef and/or veal), including ground beef, hamburger, veal patties, and beef patty mix, that may be distributed to consumers as such.
4 See FSIS Directive 10,010.1, dated 2/1/98, "Microbiological Testing Program for Escherichia coli O157:H7 in Raw Ground Beef." Single copies of the Directive are available from the FSIS Docket Clerk in Room 102, Cotton Annex Building, 300 12th Street, S.W., Washington, DC 20250-3700 from 8:30 a.m. to 4:30 p.m., Monday through Friday, except Federal holidays.
Question 11: Does FSIS intend to change the sample collection instructions contained in sections VI ("Sample Collection Instructions at Inspected Establishments") and VII ("Sample Collection Instructions at Retail Outlets") of FSIS Directive 10,010.1?
Answer: FSIS is reviewing the prescribed circumstances in which FSIS inspection program personnel are not to collect samples of raw ground beef products. FSIS expects to add an additional option for suppliers of boneless beef that use validated pathogen reduction interventions on beef carcasses. In addition, FSIS expects to clarify the FSIS inspection program personnel verification activities that are to be carried out to verify that an establishment's operations meet the prescribed circumstances under which FSIS inspection program personnel are not to collect samples of raw ground beef products. Finally, FSIS is reviewing its sample collection instructions at retail outlets and is considering establishing for retail outlets specific conditions, similar to those already established for inspected establishments, in which FSIS inspection program personnel will be instructed not to collect samples of raw ground beef products.
Question 12: If beef cuts are sampled prior to adding a marinade, and an E. coli O157:H7 positive result is obtained, is the marinated beef product adulterated?
Answer: If the surface of the beef was not scored to facilitate the incorporation of the marinade, the product remains intact. FSIS stated in its January 19 Notice on E. coli O157:H7 that intact cuts of muscle that have only surface contamination of E. coli O157:H7, that are distributed for consumption as intact cuts, are not to be considered to be adulterated. If the surface of the beef was scored, however, the product is non-intact and it is adulterated unless it is either handled for further processing into RTE product or appropriately disposed of (e.g., diverted from human food channels).
Question 13: What procedures should an establishment implement if it wants to further process beef that is contaminated with E. coli O157:H7?
Answer: The processing establishment is responsible for ensuring the proper handling of this contaminated beef and all other product that may come into contact with the contaminated beef, and this includes the proper handling of food contact surfaces. Generally, contaminated beef should be processed after all other product in a shift is handled in order to reduce the potential for cross-contamination. Two scenarios that provide further guidance follow.
Scenario A – Trimmings Processed for RTE: The trimmings are processed into raw patties, the raw patties are boxed, and the boxes are affixed with labeling that designates them for cooking. The labeling includes a code associated with a HACCP plan record entry, and the code is associated with the E. coli O157:H7 lot. Another HACCP plan record entry identifies that all of the coded product was properly cooked and accounted for. A final HACCP plan record entry identifies the destination of the RTE product.
Scenario B – Briskets with Corning Solution: The raw briskets and corning solution are vacuum packaged and affixed with a label. The label includes a code associated with a HACCP plan record entry, and the code is associated with the E. coli O157:H7 lot. Another HACCP plan record entry identifies that a purchase specification has been negotiated with a specific retail outlet. In addition, the purchase specification specifies that the corned briskets in their retail-ready packaging will be either sold in their packaging or returned to the official establishment at the end of their use-by date. Another record entry identifies the planned procedure for handling any returned corned briskets from the lot.
Question 14: Should receiving and supplying establishments notify FSIS when a sample of any livestock or poultry product is positive for E. coli O157:H7?
Answer: Currently, there is no regulatory requirement for establishments to notify FSIS whenever a sample of livestock or poultry product is positive for E. coli O157:H7. Establishments that implement testing protocols for E. coli O157:H7 should have testing records that document positive and negative results. These testing records should be available to FSIS inspection program personnel. FSIS would like to have as much information as possible on the incidence of E. coli O157:H7 contamination. FSIS encourages establishments and others to notify the agency whenever E. coli O157:H7 is found in regulated products so that FSIS can update its information about the occurrence and the levels of this pathogen at all points along the farm-to-table continuum, and can take appropriate action to protect the public health.
[FRO157-10Q&A.doc]
For Further Information, Contact:
FSIS Food Safety Education and Communications Staff
Room 1175-S, 1400 Independence Ave., S.W.
Washington, D.C. 20250
Phone: (202) 720-7943
Fax: (202) 720-1843