Sampling Verification Activities for Shiga Toxin-Producing Escherichia Coli (STEC) in Raw Beef Products - Revision 5

FSIS directive 10010.1

Series Type 10000 Series: Laboratory Services

Issue Date Feb 27, 2023

Full Directive

10010.1.pdf

NOTE: Fundamental changes in sampling procedures have been made in this revision. Agency personnel are to read Chapter I, Section III. SIGNIFICANT CHANGES below for information and to focus on understanding the information reflected there.

CHAPTER I - GENERAL

PURPOSE
1. This directive provides instructions to inspection program personnel (IPP) for collecting and submitting samples of raw beef products under FSIS's routine and follow-up sampling programs for Shiga toxin-producing Escherichia coli (STEC) and for updating the Public Health Information System (PHIS) profile information related to sampling. FSIS tests all raw beef samples collected under the routine and follow-up sampling programs for seven adulterant STEC serogroups (E. coli O157, O26, O45, O103, O111, O121, and O145) and Salmonella.
2. Instructions concerning STEC verification activities other than FSIS sampling are contained in FSIS Directive 10010.2, Verification Activities for Shiga Toxin-Producing Escherichia coli in Raw Beef Products. FSIS Directive 10010.2, Chapter III, Section I, provides IPP with instructions for responding to positive results from FSIS verification testing. FSIS Directive 10010.3, Traceback Methodology for Escherichia coli (E. coli) O157:H7 in Raw Ground Beef Products and Bench Trim, provides instructions to Enforcement, Investigations, and Analysis Officers (EIAOs) and other IPP concerning traceback investigations, recalling product, and high event periods.
3. This directive provides instructions to IPP for sampling beef manufacturing trimming, bench trim and certain follow-up sampling projects with the cloth sample collection method instead of N60 excision sampling.
  
  NOTE: For the purposes of this directive when the directive references "raw beef" it includes veal and not-ready-to-eat (NRTE) beef.
CANCELLATIONS
FSIS Directive 10,010.1, Revision 4, Verification Activities for Escherichia coli O157:H7 in Raw Beef Products, 08/20/2015
SIGNIFICANT CHANGES
1. This directive:
  1. Explains that all raw beef samples collected under all MTxx sampling tasks will be analyzed for seven adulterant STEC serogroups and Salmonella per 87 FR 69242.
  2. Provides instruction on final products to be listed in the PHIS profile to generate raw beef sampling tasks (MTxx) and how to verify that the establishment's PHIS profile is accurate to ensure that the establishment is eligible for raw beef sampling.
  3. Provides new instructions to IPP at "sister" establishments on completing the PHIS profile. See Chapter III Section I.
  4. Includes instructions for how IPP are to sample products that are sent off-site for intervention. See Chapter IV Section IV.
  5. Includes instructions for IPP sample collection of beef manufacturing trimmings, bench trim, and certain follow-up sample tasks utilizing the cloth sample collection method per 87 FR 71291.
  6. IPP are to be aware that new PHIS codes have replaced the current MTxx codes which are affected by the sampling method change. The cloth sample collection method will only be used when beef manufacturing trim or bench trim is to be sampled.
    1. MT60_C replaces MT60;
    2. MT65_C replaces MT65;
    3. MT52_C replaces MT52;
    4. MT53_C replaces MT53; and
    5. MT44T_C replaces MT44T.
  7. There is no change in product eligibility for raw beef sampling. Product eligibility is based on the product's intended use.
  8. IPP at import establishments will continue to collect beef trim samples (MT51) using the N60 excision sample collection method, regardless of whether the product is frozen or unfrozen to ensure consistency in sampling at import establishments.
  9. IPP are to be aware of MT52_C follow-up sampling changes as described in Chapter VII, Section III, B.
BACKGROUND
1. All raw non-intact beef and raw intact beef intended for use in raw non-intact product are adulterated under the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601(m)(1)) when they are contaminated with E. coli from one of seven serogroups (O157, O26, O45, O103, O111, O121, and O145) and the Shiga toxin (stx) and Intimin (eae) genes are present.
2. FSIS sampling verifies that an establishment's controls or food safety procedures adequately address STEC.
3. FSIS requires establishments to hold or maintain control of raw beef products that FSIS has tested for STEC pending negative results.

CHAPTER II - ELIGIBILITY CRITERIA FOR FSIS STEC SAMPLING

DOMESTIC SAMPLING
1. IPP are to be aware that FSIS samples and tests eligible raw beef products produced under inspection, before such products can be marked inspected and passed. The retail exempt processing requirements (9 CFR 303) specify that only inspected and passed product sources are to be used. Products cannot be used for retail exempt processing, whether onsite or at another facility, until it completes the inspection process, including any FSIS sampling of eligible raw beef products when applicable.
2. Establishments that slaughter and further process raw beef product may be eligible for multiple MTxx sampling programs. These establishments may produce ground product, beef manufacturing trimmings from cattle slaughtered onsite, and raw ground beef components other than trim. Additionally, these establishments may use purchased product intended for intact use to produce bench trim or raw non-intact products. Therefore, IPP may receive sampling tasks for MT43, MT60_C, MT64, and MT65_C samples during the same sampling window.
3. As described below and outlined in Figure 1, FSIS has four routine raw beef sampling programs for official establishments. There are three source material sampling programs (MT60_C, MT64, and MT65_C) to sample intact beef intended for non-intact use or when the intended use is unclear and one sampling program (MT43) to sample certain finished raw ground beef products. A brief description of each project and eligible products is included below.
  
  NOTE: Non-intact beef products include: ground beef; chopped beef; flaked or minced product; beef that is vacuum tumbled with solutions; beef that an establishment has mechanically tenderized by needling (including injecting with solutions), cubing, pounding devices (with or without marinade); beef that an establishment has reconstructed into formed entrees; beef with proteolytic enzymes applied; and diced beef less than ¾ inch (dial setting) in any one dimension on average.
  1. MT60_C Beef Manufacturing Trimmings- Sampling of intact beef slaughtered onsite when the intact product is intended for non-intact use or when the intended use is unclear. These can be beef products of any size except for carcasses, halves, and quarters. MT60_C eligible products include, but are not limited to:
    1. Boneless beef of any size, in boxes, combos or other containers the producing slaughter establishment intends for raw non-intact use;
    2. Two-piece chucks (i.e., the blade portion and an arm roast from the forequarter individually packaged and placed into the same container); and
    3. Smaller pieces of trimmings from subprimal cuts when the beef was slaughtered on-site.
    NOTE: Intact products intended for raw non-intact use or when the intended use is unclear are eligible for MT60_C sampling even when the meat is made non-intact at that specific establishment, or at another off-site location.
  2. MT64 Raw Ground Beef Components Other Than Trim- Sampling of raw ground beef components other than trim from beef slaughtered onsite when the product is intended for non-intact use or the intended use is unclear. MT64 samples are collected from:
    1. Head meat;
    2. Cheek meat;
    3. Weasand meat;
    4. Heart meat;
    5. Meat produced from Advanced Meat Recovery (AMR) systems;
    6. Low temperature rendered product (LTRP), such as partially defatted chopped beef (PDCB), partially defatted beef fatty tissue (PDBFT), and low temperature rendered lean finely textured beef (LTRLFB); and
    7. Ammoniated beef products (produced at slaughter and non-slaughter establishments).
  3. MT65_C Bench Trim-Sampling of beef not slaughtered on-site and originally intended for intact use by the slaughter establishment. The product becomes eligible for MT65_C when some, or all of the product originally intended for intact use (typically vacuum packaged primals and subprimals) are designated for non-intact use (or the intended use is unclear) by the receiving establishment. MT65_C samples are collected from, but are not limited to:
    1. Beef of any size, prior to the non-intact process (e.g., tenderization, grinding) that the slaughter establishment intended for intact use, but is used by the receiving establishment to make a non-intact product;
    2. Beef of any size that the slaughter establishment intended for raw intact but is used by the receiving establishment to make product intended for non-intact use or the intended use is unclear. For example, chucks, loins, or rounds that were not originally eligible for MT60_C sampling as the slaughter establishment intended the product for intact use, but the receiving establishment changed the intended use to intended for non-intact use for some or all the received product;
    3. Raw ground beef components other than trim (e.g., head meat) or that the slaughter establishment intended for intact use but is used by the receiving establishment to make a non-intact product (e.g., ground beef), a product intended for non-intact use (e.g., beef for grinding) or the intended use is unclear; and
    4. Primal and subprimal cuts derived from purchased whole, half, or quartered carcasses provided that the further processers intend those products for raw non-intact use (e.g., grinding or mechanical tenderization).
  4. MT43 Ground Beef- Sampling of certain finished non-intact products including:
    1. Those that meet the standard of identity as listed in 9 CFR 319.15.
      1. 319.15(a) chopped or ground beef;
      2. 319.15(b) hamburger; and
      3. 319.15(c) beef patties;
    2. Other raw beef products that do not meet the standards of identity in 9 CFR 319.15 but are produced similarly, such as:
      1. Raw ground beef products with added ingredients or seasonings (beef patties with cherries, beef patty mixes);
      2. Ground beef with one or more different species where beef is the predominant species (e.g., finished ground product is 50% or more beef); and
      3. NRTE ground product that receives a heat treatment but is not fully cooked (e.g., char-marked heat-treated but not fully cooked beef patties, chicken fried steak type product, or breaded beef patty that is heat treated but not fully cooked.
4. Some slaughter establishments use beef manufacturing trimmings and other raw ground beef components to produce raw ground beef. In this situation, IPP are to sample the beef manufacturing trim under the MT60_C sampling program, the other components under the MT64 sampling program, and raw ground beef product under the MT43 sampling program. IPP are not to collect the MT43 sample from the same beef lot already sampled for MT60_C or MT64.
5. Establishments are eligible for both the MT65_C and MT60_C sampling programs if they use certain types of purchased product to produce bench trim (MT65_C) and source materials from their own slaughter operation to produce beef manufacturing trimmings (MT60_C) (see Figure 1 of this chapter).
6. FSIS tests all raw beef samples collected under routine and follow-up sampling programs for STEC and Salmonella.
7. The maximum number of routine sampling tasks assigned each month is included in table 1 below.
8. In the event of a positive sample from any of the routine domestic sampling programs, follow-up samples will be scheduled at the establishment. The purpose of scheduling these follow-up samples is to determine whether the establishment effectively addresses STEC. Table 2 below, provides a general description for each of the domestic follow-up sampling programs (MT44, MT52_C, MT53_C, MT44T_C). IPP are to refer to this table, as needed, when they receive follow-up sampling tasks.
SAMPLING FREQUENCIES FOR ROUTINE SAMPLING PROGRAMS
1. IPP are to be aware that FSIS has a set minimum number of sampling tasks for each establishment when eligible products are entered into PHIS. IPP are to be aware that a product group must be deleted from the PHIS products page to prevent it from generating MTxx sample tasks. Thus, a product group with 0-pounds per day will continue to generate MTxx sample tasks. PHIS will assign to each establishment that:
  1. Produces raw ground beef products at least three MT43 sampling tasks per year; and
  2. Produces bench trim, other raw ground beef components, or beef manufacturing trimmings the corresponding sampling task at least once per year for each product.
2. If IPP do not receive the minimum number of sampling tasks, IPP are to:
  1. Verify the necessary finished product and intended use information in the establishment's PHIS profile products page (see Chapter III).
    
    NOTE: If MT60_C eligible products are entered into PHIS, but the establishment has not slaughtered any class of cattle, as indicated in the Animal Disposition Reporting module of PHIS, PHIS is designed to override those product group entries and will not assign any MT60_C sample tasks.
  2. Allow up to 45 days after making a change for PHIS to recognize the change and distribute sampling tasks as part of the routine monthly distribution of tasks. If IPP made changes to the PHIS profile to generate sampling tasks, they are to contact Risk Management and Innovations Staff (RMIS) if they have not received sampling tasks within 45 days.
  3. Contact the RMIS through the "Sampling" inquiry type at askFSIS if the information in the PHIS profile is accurate, and they are still not getting the MTxx sample tasks.
3. IPP assigned to establishments with higher production volumes will likely receive more sampling tasks than those assigned to establishments with lower production volumes.
4. Table 1 provides information on the maximum number of sampling tasks for routine sampling programs that IPP may receive monthly based on the establishment's production volume.
  
  NOTE: The maximum frequencies in Table 1 only apply to routine sampling programs. In the event that follow-up sampling is necessary in response to an FSIS or AMS positive result, IPP will receive these sampling tasks at a rate greater than listed in table 1 (see Chapter VII, Section II.C.).
INTENDED USE AND SAMPLING ELIGIBILITY
1. The product's intended use is a key factor in determining whether FSIS collects samples. FSIS samples products intended for use in raw non-intact product (e.g., ground, mechanically tenderized, needled, and vacuum marinated), or when the intended use is unclear.
2. IPP are not to sample product that the establishment intends for use in intact or ready-to-eat product, or product that will receive other full lethality treatment at another federally inspected establishment. If the product is to receive a full lethality treatment at another federally inspected establishment, IPP are to verify that the establishment's hazard analysis and flow chart show that the product is intended for one of these controlled uses, and that the establishment has controls that ensure that the product is used as intended. If not, IPP are to collect the sample. Examples of full lethality treatments other than cooking can include high pressure processing (HPP) and irradiation (IR), provided that the establishment has supporting documentation that shows the treatment achieves a 5-log reduction for Salmonella and applies the treatment consistent with its critical operational parameters.
3. When establishments do not maintain clear records concerning the intended use of raw ground beef product, beef manufacturing trimmings, bench trim, or other raw ground beef components, IPP are to consider that these products are intended for use in the production of raw non-intact products. Such products are subject to FSIS sampling and testing for STEC.
4. If a product is subject to being sampled, IPP are to sample the product even if the establishment decides to change the product's intended use (e.g., to cook all the product represented by the sample or to send the product to another establishment to cook the product after FSIS has collected the sample). In this situation, IPP are to proceed with submitting the sample to the FSIS laboratory for analysis.
5. IPP are to use the information in Chapter II to determine whether the products produced by the establishment are subject to routine FSIS sampling and testing and then are to perform the "Update Profile" task as needed as described in Chapter III.
IMPORT SAMPLING
Table 3 below provides a general description of eligible products for each of the routine import sampling programs (MT51 and MT08). Import inspection personnel are to refer to this table, as needed, when they receive sampling tasks for imported product.

CHAPTER III - PHIS PROFILE RESPONSIBILITIES

MANAGING THE PHIS PROFILE
1. IPP assigned to establishments producing raw beef products are to perform the "Update Profile" task as needed and schedule it on the task calendar.
2. IPP are to determine whether the establishment produces product eligible for MT43 raw ground beef product sampling (See Chapter II). If IPP determine that raw ground beef product sampling is required, they are to review the establishment profile and update the profile, if needed, to make the establishment subject to MT43 sampling (See Table 4). IPP are to complete this task no later than 30 days after the issuance of this directive.
3. IPP are to be aware that the PHIS finished product names determine which MTxx sampling task(s) will be assigned. IPP are also to be aware that in accordance with FSIS Directive 5300.1, Managing the Establishment Profile in the Public Health Information System, only finished products (those shipped from the establishment) should be entered into PHIS. Intermediary products should not be entered into PHIS. For example, if the establishment makes beef manufacturing trimmings but uses all of those trimming in-house to make ground beef, beef manufacturing trimmings should NOT be listed in the PHIS profile. Only if the establishment intends to ship some, or all, of the beef manufacturing trimming into commerce, would beef manufacturing trimmings be entered as a finished product.
4. A "sister" processing establishment that produces trim intended for non-intact use from carcasses, carcass halves, or quarters supplied by a single slaughter establishment within the same ownership structure were previously eligible for the MT60_C sampling project. Effective with the issuance of this Directive, (revision 5), these trim products previously eligible for MT60_C will now be eligible and collected under the MT65_C sampling project code at the "sister" receiving processing establishments.
  1. Upon issuance of this Directive, (revision 5), IPP at the "sister" processing establishment are to schedule a Directed Establishment Profile Update task and update the PHIS profile. IPP are to follow the instructions in FSIS Directive 5300.1 to enter final products produced at the establishment when they further process received or purchased products (whether or not there is an actual financial transaction). For example, if the "sister" processing establishment produces ground beef from bench trim, the final product group is "ground beef/hamburger/beef patty product from purchased source materials intended for intact use." If the "sister" processing establishment ships bench trim as a final product, the IPP are to enter bench trim into the PHIS profile Products page and select the Product Group, "Bench Trim (trimmings from animals not slaughtered at the Est.)."
  2. IPP are to delete from the "sister" processing establishment's Profile Products page the raw intact beef product with Product Group "Trim produced by "sister" processing establishment."
5. IPP are to update the profile as soon as possible when there are production changes that could affect the scheduling or frequency of sampling tasks. Attachment 1 provides instructions to IPP for selecting a product name and which MTxx sampling requests are associated with that name.
6. IPP are to enter each product the establishment produces according to the product's intended use. IPP are to enter the volume associated with the intended use and the number of days per month this product is produced.
7. IPP are to delete the same product groups that have the same intended use identified.
8. When IPP make changes to the establishment profile, they are to share the changes with establishment management during the weekly meeting. If the establishment disagrees with the changes, IPP are to update the profile with changes establishment management can substantiate (e.g., more accurate production volume information).
9. When the establishment changes the finished products it produces or the product's intended use, IPP, as part of the monthly PHIS profile task, are to follow the instructions in FSIS Directive 5300.1, to update the finished products information in the PHIS profile, so that the establishment is subject to the correct sampling tasks.
10. IPP are to follow the instructions provided in FSIS Directive 13000.2, Performing Sampling Tasks in Official Establishments using the Public Health Information System, to cancel a sampling task when the product is intended for use in RTE product or to receive another full lethality treatment at a federally inspected establishment only (see Chapter II, Section III). IPP are to also cancel a sampling task when the product does not bear a mark of inspection because it is processed under a retail exemption, or the product is produced from cattle slaughtered under a custom exemption. Such product is not eligible for the mark of inspection nor sampling by Office of Field Operations (OFO) inspection personnel.
11. In the event IPP receive a sampling task for a sampling program for which the establishment is not eligible, IPP are to indicate "Requested sample/product never slaughtered/produced" as the reason for canceling the task. IPP are to note that canceling a task and providing this justification does not ensure that IPP will not receive additional sampling tasks. IPP are to ensure the Establishment Profiles is accurate and up to date. If IPP receive a sampling task, and the establishment is not eligible for sampling, they are to review the establishment profile to make sure it is accurate and make necessary changes to correct the information in the profile.
12. Table 4 shows the finished product groups in PHIS that will generate specific sampling tasks. Attachment 1 includes a table with instructions on when IPP should enter specific finished product names into PHIS and the sampling request generated by that name. IPP are to use Table 4 and Attachment 1 when completing the PHIS profile to ensure the correct sampling tasks are assigned to the establishment.
  
  NOTE: Establishments will not be subject to specific sampling tasks in PHIS if all of the finished product category eligible under the sampling scheduling criteria in the PHIS profile are marked as "intended for RTE only."
SUPERVISORY RESPONSIBILITIES CONCERNING THE PHIS PROFILE
1. Supervisory personnel are to review the PHIS establishment profiles. Supervisory personnel are to ensure that IPP have accurately entered PHIS profile information as described in Section I of this chapter, so that establishments are recognized in PHIS as eligible for the appropriate MTxx sampling tasks.

CHAPTER IV - SAMPLE COLLECTION PREPARATION

PREPARING TO COLLECT A SAMPLE OF RAW PRODUCT FOR STEC VERIFICATION TESTING
1. IPP are to provide enough time for the establishment to hold the sampled lot but not enough time to alter the process. To provide establishments enough time to hold the entire sampled lot, IPP are to:
  1. Be knowledgeable concerning the establishment's production practices;
  2. Provide 1 days' notice if such advance notice is sufficient for the establishment to hold the sampled lot. IPP may also provide 2 days' notice, if necessary. The amount of time needed for the establishment notification is not to impede FSIS's ability to conduct verification activities that are representative of the establishment's actual production practices. If less than 1 day's advance notice would not cause a hardship for the establishment, IPP may provide less than 1 days' notice before FSIS collects a sample for STEC testing;
  3. Consider establishment requests for more than 2 days' notice before collecting the sample based on the establishment's product and process flow. In some cases, based on this consideration, IPP may agree that more than 2 days' notice is necessary. For example, if an establishment makes case-ready product and requests that the inspector give a notice of 2 days before taking a sample, the inspector is to accommodate this request to allow the establishment to adjust production levels to fill its orders but still hold the sampled lot. If IPP have questions about an establishment's basis for requesting more notice, they are to discuss their concerns with their supervisor;
  4. Inform the establishment that it is responsible for supporting its basis for defining the production lot represented by the sample (i.e., the sampled lot); and
  5. Inform the establishment that it is required to hold or maintain control of the sampled lot when FSIS collects samples for STEC until negative results become available.
2. IPP are to be aware that FSIS does not recognize "Clean-up to clean-up" alone as a supportable basis of distinguishing one portion of production from another portion of production.
3. IPP are to be aware that factors or conditions that may determine the sampled lot include:
  1. Any scientific, statistically based sampling programs for STEC that the establishment uses to distinguish between segments of production;
  2. Sanitation Standard Operating Procedures (Sanitation SOPs) or any other prerequisite program used to control the spread of STEC cross-contamination between raw beef components during production. The following may lead to the cross-contamination between raw beef components during production:
    1. Improper sanitary dressing procedures;
    2. Insanitary product contact surfaces on equipment such as machinery and employee hand tools; and
    3. Improper employee hygiene;
  3. Processing interventions that limit or control STEC contamination; and
  4. Beef manufacturing trimmings and raw beef components or rework carried over from one production period to another.
4. If multiple lots of raw ground beef product were produced from source materials from the same production lot from a single supplier, and some of this product was found positive for STEC, IPP are to be aware that a scientific basis is necessary to justify why any raw ground product produced at the establishment from those source materials should not be considered to be adulterated.
  
  NOTE: When IPP are assigned to an unfamiliar establishment, they are to discuss sampling with the establishment during the entrance meeting. As part of this discussion, IPP are to determine how much notice to give the establishment before collecting a sample.
SCHEDULING SAMPLES IN PHIS
When IPP are assigned STEC sampling tasks in PHIS, they are to schedule the sampling task within the sampling window. IPP are to follow the instructions provided in FSIS Directive 13000.2, and in the PHIS User Guide for scheduling and completing the sampling task using the PHIS.
ORDERING SAMPLING SUPPLIES
1. The FSIS laboratories will ship STEC sampling supplies automatically to the Inspector-in-Charge (IIC) at the establishment. IPP are to use only the sampling supplies provided by the FSIS laboratories.
2. If IPP do not receive sampling supplies by the first day of the collection window, or need replacements for damaged or lost supplies, they are to request sampling supplies.
3. To request sampling supplies via PHIS, IPP are to right-click a scheduled lab sampling task (e.g., "MT60_C") on the Task Calendar, then select "Order Supplies" from the drop-down menu.
4. If IPP are unable to request supplies via PHIS, they are to request sampling supplies via Outlook, IPP are to select one of the following addresses according to the District / Lab assignments as listed below:
5. IPP are to use the subject heading "MTxx Sampling Supplies", specifying the MTxx sample project supplies are being requested for, and the IPP's contact name, establishment number, telephone number, and a list of the supplies needed.
6. When returning supplies, IPP are not to use any shipping labels included with supplies since they are labels for express delivery that are charged more than a standard ground box. IPP are to contact the lab within their region as listed below and use "Return Supplies" in the e-mail subject heading to send unused boxes back to the laboratories.
  1. SamplingSupplies-EasternLab@usda.gov; Atlanta (85), Raleigh (80), Philadelphia (60), and Jackson (90).
  2. SamplingSupplies-MidwesternLab@usda.gov; Des Moines (25), Springdale (35), and Chicago (50).
  3. SamplingSupplies-WesternLab@usda.gov; Alameda (05), Denver (15), and Dallas (40).
GENERAL SAMPLING INSTRUCTION FOR ROUTINE STEC SAMPLING
1. IPP are to notify establishment management before collecting samples. IPP are to inform the establishment of the reason they are collecting the sample (e.g., routine FSIS verification testing or follow-up sampling in response to an STEC positive from FSIS or AMS testing).
2. IPP are to use a method for randomly selecting the product for sampling. IPP are to randomly select a day, shift, and time within the sample window after the sample collection date indicated in PHIS. IPP are to collect samples from all shifts the establishment operates and include Fridays in the random selection. There needs to be an equal chance that sampling will occur during any particular shift.
3. IPP may be assigned more than one sampling task during the same sampling window in an establishment that produces raw ground beef product, beef manufacturing trimmings, other raw ground beef or beef patty components, and bench trim or raw non-intact product from purchased product. A beef product is only eligible for one of the source material sampling tasks (MT60_C, MT64, or MT65_C) but any source material sampled under MT60_C, 64, or 65_C is also eligible for MT43 sampling if made into eligible ground beef type products as listed in Chapter II.
  1. IPP are not to collect a raw ground beef sample from the same lot of source materials (i.e., beef manufacturing trimmings, bench trim, or other raw ground beef components) that other IPP have already sampled.
  2. If the establishment produces 1,000 pounds of product or less on a daily basis, or only on an intermittent basis, IPP are only to collect one sample. IPP are to sample beef manufacturing trimmings under the MT60_C, sampling program. IPP are to collect the MT43 sample on another day within the sampling window if product is available.
  NOTE: As described in Chapter III, IPP are to enter product production volumes and the number of days per month products are produced in PHIS.
4. IPP are to collect fresh and not frozen product for STEC sampling. IPP are only to collect a sample of frozen product if the establishment has a critical control point (CCP) for freezing in its Hazard Analysis Critical Control Point (HACCP) plan, and freezing is an active process that achieves a reduction in STEC (e.g., a spiral freezer).
5. IPP are to collect the sample after the establishment has completed production of a lot (as defined by the establishment) and applied all antimicrobial treatments to the product to be sampled.
  
  NOTE: Application of an antimicrobial treatment (other than a treatment that achieves a full lethality) does not exempt the product from routine sampling.
6. HPP or IR can be applied in a manner that achieves full-lethality or applied so that full-lethality is not achieved. As described in Chapter II, Section III. B., if the product is to receive a full-lethality at a federally inspected establishment, including off-site, IPP are to verify that the establishment's hazard analysis and flow chart show that the product is intended for this use, and that the establishment has controls that ensure that the product is used as intended, and the establishment does not complete pre-shipment review until these treatments have been applied IPP are to verify, through records review, that the establishment maintains sufficient documentation to support its assertion that product receives an intervention off-site and has scientific support for the specific parameters applied and log reduction achieved
  1. IPP are to sample product that is sent off-site for an intervention (e.g., HPP or IR) that does not achieve a full lethality (i.e., less than a 5-log reduction for Salmonella) when the product is returned to the original establishment. If the product is not returned to the producing establishment after the HPP/IR treatment, IPP are to sample other product, if possible, on that day or within the sampling window. If the establishment is not producing any other eligible products during the sampling window, IPP are to cancel the task and enter into PHIS "all interventions have not been applied at this establishment."
  2. When the products are treated with HPP or IR for quality purposes and not to control pathogens, IPP are to perform microbiological verification sampling of the product prior to the application of the quality treatment.
7. IPP are to collect a sample even if an establishment has already tested the production lot for STEC.
8. If the establishment intends to test the product for any of the adulterant STEC before completing pre-shipment review, IPP are not to wait for the establishment to receive the test results before collecting the sample. Each time IPP collect samples tested for STEC, they are to verify that establishments are holding or maintaining control of the sampled lot.
9. If an establishment does not hold or maintain control of product tested by FSIS for STEC, IPP are to write a noncompliance record (NR) because the establishment shipped product before FSIS found that the product was not adulterated, and because the establishment did not complete pre-shipment review following availability of all relevant test results, as required in 9 CFR 417.5(c). In this situation, IPP are to immediately contact the district office (DO).
ALTERNATIVE SAMPLING PROCEDURES FOR RAW GROUND BEEF PRODUCT (MT43) SAMPLING
1. General
  1. Alternative sampling procedures only apply to raw ground beef product (MT43) sampling. Alternative sampling procedures are different from alternative lotting described in Section VI of this chapter. IPP are to follow the instructions below for these alternative sampling procedures when collecting a raw ground beef sample for MT43 sampling, provided establishments meet the specific requirements applicable to each alternative sampling procedure.
  2. Alternative sampling procedures include:
    1. Grinding a minimum batch of product; and
    2. Sampling a lot at the start of production.
    NOTE: In the event of a positive result, IPP are to be aware that FSIS considers all same source materials used to produce the positive raw ground beef product to be positive unless the establishment has a scientific basis to distinguish production lots using same source materials (i.e., robust sampling of source materials or finished product or the application of a validated antimicrobial intervention to source materials or finished product according to the establishment's supporting documentation).
2. Grinding a Minimum Batch of Product. An establishment may request that FSIS sample product from a minimum batch of product that represents the entire lot on a smaller grinder.
  1. In this case, IPP are to verify that:
    1. The establishment has written procedures to grind a minimum batch of product that represents the establishment's production process in a smaller, off-line grinder;
    2. The establishment has supporting documentation that describes how the minimum batch is representative of the establishment's production process. As part of the verification that the minimum batch represents the establishment's normal process, IPP are to ensure that the documentation includes an appropriate proportion of all types and suppliers of trim used to produce the larger production lot; and
    3. The minimum batch is not less than 50 pounds.
  2. If the establishment meets the criteria in B. 1, IPP are to sample this minimum batch of product after randomly selecting the day, shift, and time and notifying the establishment as set out in Section I and Section IV of this chapter. If the establishment does not meet the criteria, IPP are to collect the sample as described in Chapter V.
3. Sampling a Lot at the Start of Production. An establishment may request that FSIS sample a lot of raw ground beef product at the start of production.
  1. In this case, IPP are to verify that the establishment has production schedules that define the specific components used at specific production times.
  2. If the establishment does operate in accordance with schedules of this type, IPP are to:
    1. Randomly select a production date and time within the sample collection window on the task calendar in PHIS;
    2. Select a time of production for sampling that is after the beginning of operations. If the establishment has documentation showing that it is scheduled to grind a specific lot of product at a specific production time, IPP are to allow the establishment to grind that lot of product at the beginning of operations on the day that PHIS schedules IPP for a sampling task; and
    3. Verify that the establishment is not treating the source materials of the raw ground product that FSIS samples differently from other source materials used for grinding. For example, IPP are to verify that the establishment is not using interventions on the source material that it does not normally use on the ground product FSIS will sample.
  3. If an establishment requests that FSIS sample raw ground beef product at the start of production, and it meets all these criteria, IPP are to collect samples at the start of production. If the establishment does not meet the criteria, IPP are to collect the sample as described in Chapter V.
ALTERNATIVE LOTTING FOR RAW GROUND BEEF PRODUCT (MT43), BEEF MANUFACTURING TRIMMINGS (MT60_C), OTHER RAW GROUND BEEF COMPONENTS (MT64), AND BENCH TRIM (MT65_C) SAMPLING
1. An establishment may request to reduce its lot size to one combo bin or some other unit (e.g., box) for samples of raw ground beef, beef manufacturing trimmings, other raw ground beef components, and bench trim on the day that FSIS collects samples.
2. In this case, IPP are to verify that the establishment:
  1. Has a validated intervention for STEC at a CCP in the HACCP plan under which the beef manufacturing trimmings or other raw ground beef components are produced or requires its suppliers to have a CCP where a validated intervention is applied to the source materials used to manufacture the raw ground beef product or bench trim; and
  2. Samples and tests every production lot for STEC and generally collects its samples of raw ground beef, beef manufacturing trimmings, other raw ground beef components, or bench trim across multiple combo bins or other sample units.
3. If an establishment meets the criteria in Section B. and reduces its lot size of ground product or bench trim from source materials, beef manufacturing trimmings, or other components to a single combo bin or sample unit when FSIS samples the product, IPP are to collect a sample from the single combo bin or sample unit. If the establishment does not meet the criteria, IPP are to collect the sample as described in Chapter V.
GATHERING SUPPLIER INFORMATION
1. IPP are to gather information about the source materials and suppliers at the time they collect a routine raw ground beef (MT43) and bench trim (MT65_C) sample, as well as when they do follow-up sampling to these programs (MT44, MT44T_C, MT52_C, or MT53_C). Attachment 1 of FSIS Directive 10010.3. provides IPP the supplier and source material information they are to gather at the time they collect raw ground beef and bench trim samples. This information enables FSIS to trace the raw material back to the original slaughter establishment. IPP can keep the actual label from empty packages. Establishment management can also provide information about the source materials. For imported source materials, IPP are to record the Inspection certificate number.
2. IPP are to document this information in a memorandum of interview (MOI) (see FSIS Directive 5000.1, Verifying an Establishments Food Safety System). IPP are to include "Supplier Information" in the subject line of the MOI. IPP are also to make note of any information that the establishment is unable to provide. IPP are to provide a copy of the MOI to establishment management. The information in the MOI will be available for use by IPP or EIAOs during traceback investigations as described in FSIS Directive 10010.3.

CHAPTER V - SAMPLE COLLECTION PROCEDURES

GENERAL
1. The establishment may be eligible for more than one sampling program. IPP are to sample beef components, beef manufacturing trimmings, and bench trim separately and under their respective sampling codes following the instructions provided in this Chapter. When the establishment produces multiple types of trim or components, IPP are to randomly select beef manufacturing trimmings, bench trim, and beef components and collect samples under their respective sampling codes. For a given sampling event, IPP are to collect only one type of trim or component type, whenever possible. The intent is that, through random selection, all eligible products the establishment produces that are subject to sampling will likely be selected over time. IPP are to collect bench trim under the MT65_C code even if the establishment has mixed in beef manufacturing trim from animals slaughtered on site.
2. If the establishment packages product in combo bins, then IPP are to select one random combo bin from the specific production (e.g., day's production) available for sampling with one cloth for MT60_C and MT65_C projects, and respective follow up sampling projects.
3. If the establishment packages product in boxes, totes, tubs, or containers other than combo bins, IPP are to use 1 cloth for up to 5 containers from the same lot of product for MT60_C and MT65_C sample projects. For example, if an establishment defines its lot as 3 boxes, IPP are to swab all 3 boxes using 1 cloth, for a total of 1 cloth collected and shipped to the lab. If the lot is greater than 5 boxes or containers, IPP are to randomly select 5 boxes or containers and to swab all five boxes with one cloth.
4. If the establishment uses both combo bins and other containers (e.g., boxes), IPP are to randomly select combo bins or other containers to sample and then select the product accordingly as listed in B. and C. above.
5. IPP are to use aseptic technique, including proper gloving technique, when collecting samples.
6. Attachments 2, 3, 4, and 5 contain step-by-step sample collection procedures by sampling program. These attachments are also available in IPP help-raw beef sampling.
  1. Attachment 2 - MT60_C beef manufacturing trimmings and MT65_C bench trim cloth sampling instructions.
  2. Attachment 3 - MT64 components other than trim grab sampling instructions.
  3. Attachment 4 - MT43 ground beef grab sampling instructions.
  4. Attachment 5 - MT51 frozen trim N60 excision sampling instructions.
FINAL PACKAGING
1. IPP are to collect raw ground beef products in their final package whenever possible. IPP are to collect the appropriate number of packaged products so that the sample equals two pounds.
2. IPP are to place the product collected in its final packaging in the larger, non-sterile bag provided with the sampling supplies. IPP are not to use the roll top bags when collecting products in its final packaging.
Cloth Sampling Procedure
1. IPP are to watch the cloth sampling training video on IPP help found here: Cloth Sample Collection Method. The cloth sampling video can also be found on the internet here FSIS Cloth Sampling Procedure.
2. Prior to sample collection, IPP are to complete the following steps to maintain proper temperature during sample collection and shipment:
  1. Pre-chill nBPW upon receipt by placing it in a secure refrigerator (where the supplies will remain under FSIS control);
  2. Place gel coolant packs into the freezer for at least 24 hours before sample collection; and
  3. Pre-chill shipping containers by placing the pre-frozen gel pack(s) on top of the absorbent pads. The absorbent pads are used to line the bottom of the shipping containers.
    
    NOTE: IPP are not to freeze nBPW or the sample.
3. MT60_C and MT65_C Sample Procedure
  1. IPP are to wash and dry hands to the mid-forearm;
  2. IPP are to remove the clear, perforated plastic shrink wrap from the tube of nBPW and set the nBPW aside;
  3. Prior to gloving and without touching the cloth, IPP are to drop the folded cloth onto the surface of the product using the following procedures (see photos below).
    1. Open the bag by removing the perforated strip at the top of the bag. Pull the tabs to open the wire mouth of the bag wide. Once the bag is open invert the bag to drop the cloth and allow the dry cloth to drop onto the surface of the product. If the cloth does not come out of the bag, IPP are to use one hand (on the outside of the sample bag) to push the dry cloth to the top of the sample bag and then invert again. Do not touch the cloth with bare hands.
    2. Place the empty plastic outer bag in an upright position on a clean, sanitary surface such as a sample caddy/tote or table within suitable distance of the sampling area. This positioning will facilitate placement of the cloth back in the bag once the sampling procedure is complete;
  4. Put on arm sleeves and non-sterile gloves over the sleeves. Using an alcohol-based spray sanitizer (available from the FSIS Material Management Supply Center ), IPP are to sanitize gloved hands and plastic sleeves simultaneously. Ensure there is no excess sanitizer on the gloved hands or forearm sleeves before touching the cloth and beginning the sampling procedure;
    
    NOTE: IPP are to order sanitizer from the FSIS Material Management Supply Center in advance of collecting samples.
  5. IPP are to maintain sanitary conditions after sanitizing gloved hands and forearm sleeves. Do not touch anything except for the cloth;
  6. To perform this sampling procedure, after gloving and sanitizing as described above, IPP are to unfold the cloth, which is laying on top of the product in the combo/box;
  7. IPP are to visually identify a point on the combo to begin and end the sampling procedure because IPP will move around the combo in a uniform manner to massage the entire surface of the combo;
  8. Once a starting point for sampling has been identified, IPP are to tightly grasp the cloth with both hands. While using both hands, IPP are to apply downward pressure to vigorously massage the surface area of the product with the unfolded cloth;
  9. IPP are to vigorously massage the surface of the beef trim, including the spaces and crevices between meat pieces, to ensure as much of the product surface area is sampled as possible;
  10. IPP are to use one side of the cloth to massage half of the combo;
  11. At a point halfway around the combo, IPP are to flip the cloth and use the second side of the cloth to vigorously massage the remaining half of the combo until reaching the point in the combo where the sampling procedures started;
  12. The total sampling time will be a minimum of 1.5 minutes per combo bin. IPP are to vigorously massage for a minimum of 45-60 seconds per side of the cloth to ensure a thorough sample collection (total sampling time of 1.5-2 minutes);
  13. When the sampling procedure is complete, IPP are to re-fold the cloth following the original fold lines in the cloth and then add 2 additional folds to the cloth—the 2 additional folds will assist with placing the cloth into the sample collection bag. As indicated in the photo above, the cloth is to be folded while resting on the meat product in the combo;
  14. Once folded, IPP are to return the cloth to the original clear plastic sample roll top bag;
  15. Next, IPP are to carefully open the nBPW tube and aseptically pour the pre-chilled nBPW into the open bag. IPP are to ensure that the tube does not touch the inside of the bag. The tube is not to be inserted into the bag; only the buffer should contact the inside of the bag.
    
    NOTE: IPP are to be aware that FSIS laboratories will discard samples with the reason, Sampling Instructions Not Followed, if nBPW is not used.
  16. IPP are to discard the empty nBPW tube.
  17. IPP are to use gentle pressure on the outside of the roll top bag to push the cloth down into the nBPW and remove excess air from the bag;
  18. IPP are to close the roll top bag and roll/fold the top of the bag down at least 3 times to prevent leakage. IPP are to fold in the wire tabs to secure the bag and prevent leakage; and
  19. IPP are to place at least one small, barcoded label on an individual bag.
  20. IPP are to package the roll top bag containing the cloth in the box for shipping.
N60 SAMPLING METHOD
1. N60 sampling is the sample collection method IPP are to use when collecting samples of beef trim at import establishments (MT51).
2. IPP are NOT to use the N60 method when collecting MT60_C beef manufacturing trim or MT65_C bench trim unless the establishment implements freezing as an intervention to reduce STEC presence. If freezing is used as an intervention, then the sample is to be collected by the N60 excision method. IPP are to collect MT64 other raw ground beef component samples by taking aseptic grab samples (see Section V in this chapter).
3. N60 sampling involves collecting 60 thin slices from the external surfaces of beef tissues. Each sample slice should be about 3 inches long by 1 inch wide and 1/8 inch thick, as shown below. It is important to collect thin slices because the surface of the beef carcass can be contaminated through improper sanitary dressing procedures. IPP are to collect only one sample slice from each of the 60 individual pieces of trim. IPP are not to take multiple samples from a single piece of beef manufacturing trimmings unless the production lot consists of less than 60 individual pieces. Collecting thin slices from the external surface maximizes the amount of surface area sampled, which increases the likelihood of finding pathogens if they are present.
4. IPP are to use the 3 roll top bags when collecting samples using N60 procedures. IPP are to place 30 pieces in each of the two roll top bags.
  
  NOTE: When cut to the correct size, 30 sample slices should fill one roll top bag to the fill line. In the third roll top bag, IPP are to aseptically collect samples of trim from the same production lot by using a grab sample technique. For larger trim pieces, IPP are to cut the trim piece so that it fits in the roll top bag with at least 2-3 inches of space at the top of the bag.
5. IPP are to randomly select one production lot according to the establishment's lotting practices with each lot having an equal chance of being selected regardless of product location.
  1. If an establishment's specific production lot is greater than 5 containers, IPP are to select randomly 5 containers for sampling with each container having an equal chance of being selected; and
  2. If the establishment's specific production is 5 or less containers, IPP are to refer to Table 5 to determine the number of sample pieces to collect from each container.
  3. If the establishment reduces its lot size to one container and meets the alternative lotting in Chapter IV, Section VI, IPP are to collect samples from that container.
6. Some slaughter establishments may transfer beef manufacturing trimmings to another establishment that is in the same building as the slaughter establishment or separated from the slaughter facility by only a wall to ammoniate product. In some slaughter and fabrication establishments, product intended for use in ammoniated product may be moving on a conveyor belt directly into a second establishment. IPP are to sample the beef manufacturing trimmings at the slaughter establishment under MT60_C, just as if an establishment would send this product to a more distant location.
7. IPP are to use the cloth method to collect samples from primal and subprimal cuts that are used to produce mechanically tenderized products before tenderization, if IPP can safely do so. When the primal and subprimal cuts used to produce mechanically tenderized product are from cattle slaughtered onsite, IPP are to sample the primal and subprimal cuts under MT60_C. When the primal and subprimal cuts or other source material used to produce mechanically tenderized products are from purchased product arriving without a certificate of analysis (COA), IPP are to sample the primal and subprimal cuts or other source material under MT65_C.
8. IPP assigned to establishments that apply an antimicrobial and tenderize in a closed tunnel or cabinet-type system are to ask the establishment whether it has the capability and will agree to temporarily shut off the tenderizing component so that IPP can safely collect the sample after the antimicrobial treatment and before tenderization. If the establishment has this capability and agrees to do so, IPP are to collect the sample as the product exits the tunnel or cabinet after receiving the antimicrobial treatment. Once IPP collect the sample using the cloth, the establishment could then run the remainder of the product that is to be treated through the tenderizer.
9. If the establishment does not have the capability to temporarily shut off the tenderizing component or does not agree to do so, IPP are to collect the sample from the mechanically tenderized product using the cloth and note in PHIS that mechanically tenderized product has been sampled.
ASEPTIC GRAB SAMPLING
1. IPP are to aseptically collect grab samples and are not to use the Cloth sample collection method or the N60 excision method when collecting other raw ground beef component (MT64) samples.
2. IPP are to aseptically collect grab samples when raw ground beef product (MT43) is not available in its final packaging, or the package is too large.
3. For aseptic grab samples, IPP are to collect enough product to fill each of the 3 roll top bags to the fill-line. For larger components, such as hearts, IPP are to collect one or more pieces or enough to fill each of the 3 roll top bags above the fill line but leaving at least 2-3 inches of space at the top of the bag when collecting MT64 samples.
PHIS QUESTIONS RELATED TO SAMPLE MATERIAL
1. When IPP collect a raw beef MTxx sample, the sample questionnaire in PHIS asks IPP to enter the primal, sub-primal, or source material used to produce the trim or non-intact product sampled. IPP are to enter the approximate location on the carcass where source material originated from, if known. FSIS uses the data to correlate Salmonella & STEC positives with the specific areas of the animal that the meat originated (head meat, chuck, weasand, round, etc.).
  
  NOTE: The questionnaires do not instruct IPP to collect MT60_C samples directly from a carcass. The questionnaire is used as a tracking method to determine which part of the carcass the product originated (e.g., chuck trim). IPP can use Figure 2 below as an aid in determining the source area of the product sampled.
PACKING AND SHIPPING THE SAMPLE
IPP are to use only the shipping materials provided by the laboratory and refer to FSIS Directive 7355.1, Use of Sample Seals for Laboratory Samples, for complete instructions on the proper use of sample seals.
ACCESSING TEST RESULTS
1. IPP are to obtain sample results by accessing Laboratory Information Management System (LIMS)-Direct for each sample submitted. The laboratories will report the results for all adulterant STECs (E. coli O157:H7 and non-O157 STEC) for each sample in LIMS-Direct.
  
  NOTE: Results for Salmonella will continue to be displayed in LIMS-Direct under the section "Analysis Result: Non-regulatory Result" and will be displayed as being either "positive" or "negative."
2. "Not acceptable" positive test results for adulterant STEC are reported in LIMS-Direct as soon as each analysis is completed and reviewed. If the sample confirms positive STEC, LIMS-Direct will display the specific serogroup(s) that are detected. "Acceptable" test results are not reported in LIMS- Direct until after all sample analyses are completed, and the results comply with FSIS regulatory requirements.
3. After receiving the STEC test results, IPP are to advise an establishment that is holding product that it does not need to continue to hold that product if it has tested negative for STEC. IPP are to be aware that establishments are not required to hold product when only Salmonella results are pending. If IPP receive Salmonella results before the STEC results, they are to wait to notify the establishment until after receiving the STEC results.
4. Sample discard: If the FSIS Laboratory discards a sample submitted for STEC testing, IPP are to notify establishment management so that product may be released. IPP are to take appropriate action, based on the reason for the sample discard when applicable. IPP are to review the reason for sample discard and make the necessary adjustments in how the samples are collected, sealed, and shipped to ensure that the laboratory does not discard future samples because of improper handling or packaging.
  
  NOTE: There may be reasons for sample discards (e.g., FedEx issues) that are beyond IPP control.

CHAPTER VI - FSIS ACTIONS IN RESPONSE TO FSIS, OTHER FEDERAL, OR STATE ENTITY STEC TEST RESULTS

NEGATIVE STEC TEST RESULTS
IPP are to immediately notify the establishment of negative test results, so that the establishment can release product.
PRESUMPTIVE POSITIVE TEST RESULTS
When the DO receives a LIMS-Biological Information Transfer and E-mail System (BITES) notification that a sample is presumptive positive, the DO is to follow the instructions provided in FSIS Directive 10010.3.
CONFIRMED POSITIVE TEST RESULTS
In the event of a confirmed positive STEC result in raw ground beef product, beef trim, or other components intended for use in raw non-intact product, the sampled lot is adulterated. The contact person in the DO is to immediately inform IPP assigned to that establishment and the establishment management. IPP are to follow the instructions in Chapter III, Section I of FSIS Directive 10010.2, for responding to confirmed positive results.
DO RESPONSIBILITIES IN RESPONSE TO AN FSIS CONFIRMED POSITIVE TEST RESULT
1. General
  1. The DO enters information in System Tracking E. coli O157:H7-Positive Suppliers (STEPS) based on an FSIS positive result or an AMS positive result. If another Federal or State positive result led to a recall, the DO is to enter information in STEPS based on these third-party results.
  2. If the DO enters one or more establishments into STEPS that are not within its District, STEPS will automatically notify the appropriate DO. The DO that receives the notification is to repeat the steps above for establishments within its District and add any additional information into STEPS.
  3. IPP will only be instructed to collect follow-up samples from the establishment that produced the confirmed positive product and the originating slaughter establishments (see Chapter VII).
2. In response to a confirmed FSIS positive sample result, the DO is to:
  1. Access STEPS, open a case file for the incident, and follow STEPS procedures; and
  2. Direct IPP at supplying establishments to perform tasks:
    1. The DO is to direct the IPP at all establishments that supplied product represented by the positive sample, including the originating slaughter establishments that were identified in STEPS, to perform directed HACCP and Sanitation SOP verification tasks per Sections V and VI of this chapter.
    2. The DO is to direct the IPP at originating slaughter establishments to perform a directed Beef Sanitary Dressing task.
  3. Schedule a for-cause Public Health Risk Evaluation (PHRE) and after the completion of the PHRE take appropriate enforcement actions, if warranted, or schedule a for-cause Food Safety Assessment (FSA), as described in FSIS Directive 5100.4, Public Health Risk Evaluation Methodology.
3. The DO is to take the appropriate enforcement actions (e.g., Notice of Intended Enforcement, withhold or suspend inspection, reinstate a suspension), if warranted, based on EIAO or IPP findings, as described in FSIS Directive 5100.3, Administrative Enforcement Action Decision-Making and Methodology.
IPP RESPONSIBILITIES AT THE ESTABLISHMENT WITH AN FSIS, ANOTHER FEDERAL, OR STATE ENTITY CONFIRMED POSITIVE TEST RESULT
1. In the event of a confirmed positive result in raw ground beef product or beef trim or other components intended for use in raw non-intact product, the sampled lot is adulterated.
2. IPP are to perform a directed HACCP Verification task for the specific production lot that tested positive and document noncompliance, where appropriate, as described in FSIS Directive 10,010.2.
3. IPP that perform a traceback investigation as described in FSIS Directive 10010.3 in response to an FSIS or another Federal or State agency ground beef or bench trim presumptive-positive result are to use the information they gathered during the traceback investigation to perform the directed HACCP Verification task. In this situation, the only HACCP regulatory requirement that has potentially not previously been verified during the traceback investigation is corrective actions, so IPP are to verify that remaining HACCP regulatory requirement during the directed HACCP Verification task (see Chapter Two, Section III of FSIS Directive 10010.2).
4. IPP are to perform a directed Operational SOP Review and Observation task and are to verify that the establishment is properly implementing its Sanitation SOP as set out in FSIS Directive 5000.1.
5. IPP are to perform a directed Beef Sanitary Dressing task as described in FSIS Directive 6410.1, Verifying Sanitary Dressing and Process Control Procedures by Off-Line Inspection Program Personnel (IPP) in Slaughter Operations of Cattle of Any Age, if the positive sample result was from product from the establishment's own slaughter operation.
6. IPP are to collect follow-up samples as described in Chapter VII.
IPP RESPONSIBILITIES ASSIGNED TO ESTABLISHMENTS THAT SUPPLIED THE SOURCE MATERIALS USED TO PRODUCE THE POSITIVE PRODUCT
1. IPP assigned to supplying slaughter and further processing establishments are to:
  1. Perform a directed HACCP Verification task as described in FSIS Directive 10010.2 for the specific production lot of source materials used to produce the product that tested positive; and
  2. Perform a directed Operation SOP task and review records for the day or days that the source materials were used to produce the product that tested positive.
2. IPP assigned to supplying slaughter establishments are to:
  1. Perform a directed Beef Sanitary Dressing task; and
  2. Conduct follow-up sampling as described in Chapter VII.

CHAPTER VII - FOLLOW-UP SAMPLING PROCEDURES

GENERAL
1. IPP are to collect follow-up samples in response to FSIS or AMS positives as soon as possible after the positive results were obtained, unless the establishment stops producing any raw beef product intended for raw non-intact use. The purpose of follow-up sampling is to determine whether the establishment's process is effectively addressing STEC.
2. IPP are to be aware that follow-up sampling may involve a variety of products and sampling methodologies. In general, IPP are to collect follow-up samples from the same type of product that tested positive, if available. However, there are certain special circumstances when this is not the case, see E. 1 below. If the establishment is not producing the product requested, IPP are to collect follow-up samples from beef manufacturing trimmings if the establishment is producing them. For example, if head meat tested positive for STEC, then IPP are to sample head meat, if available, during follow-up sampling. If head meat is not available, IPP are to collect follow-up samples from other raw ground beef components that are available. If no other raw ground beef components are available, IPP are to sample beef manufacturing trim.
3. IPP are not to wait until the establishment takes corrective actions or has confidence that its corrective actions are effective to collect follow-up samples.
4. IPP are to continue collecting samples for a follow-up sampling task until the set is complete. Specifically, IPP are to continue collecting follow-up samples until the applicable number of samples (16 or 8 consecutive negative samples, see Section II. C. of this chapter) have been collected for each follow-up sampling set triggered. IPP may collect a maximum of 2 follow-up samples per shift per day from different lots (or up to 4 samples per day at a 2-shift establishment), unless the establishment cannot continue to operate under that sampling frequency (e.g., because the establishment cannot fill orders and hold all sampled product), or the IPP's workload cannot accommodate that sampling frequency.
  
  NOTE: The status of a follow-up set can be determined through a PHIS report and is included on set update alerts.
5. The Office of Planning, Analysis and Risk Assessment (OPARM) has automated the assigning of follow-up samples in PHIS. Follow-up sampling sets are generated in response to each positive from FSIS's routine sampling programs at the establishment that received the positive result.
  1. IPP are to be aware the follow-up sample collection methodology and product to be sampled can vary. MT53_C follow-up sample sets are assigned in a variety of different situations. IPP are to collect the following products:
    1. If a slaughter-processing establishment has a MT43 ground beef, a MT60_C, or an AMS positive result, IPP are to collect beef manufacturing trim samples under the MT53_C follow-up sample set using the cloth sample collection methodology.
    2. If a slaughter-processing establishment has an MT64 components other than trim (i.e., head meat) positive result, they are to collect the same type of component (e.g., head meat) that tested positive if available, using the grab sample collection methodology under the MT53_C follow-up sample set. If the same type of component is not available, then IPP can randomly select from any other MT64 eligible products that are available for follow-up sampling.
    3. If a downstream (processing only) establishment has an MT43 or AMS ground beef positive result, IPP are to collect ground beef samples using a grab sample collection methodology under the MT53_C follow-up set assignment.
    4. If a downstream (processing only) establishment has an MT65_C positive result, IPP are to collect bench trim samples under the MT53_C follow-up sample set using the cloth sample collection methodology.
6. FSIS also schedules follow-up sampling sets at supplying slaughter establishments in response to a positive from a raw ground beef sample from MT43, AMS sampling, or a bench trim (MT65_C) positive.
  1. Supplier follow-up sampling sets have the MT52_C project code and are discussed in more detail in Section II of this chapter.
  2. In a limited situation, FSIS will schedule a follow-up sampling set for a supplying slaughter establishment in response to a positive in ammoniated product (See Section II. D. of this chapter).
7. FSIS may also schedule a follow-up sampling set (MT44T_C) outside these follow-up sampling projects, e.g., in response to an outbreak or recall. IPP are to be aware that MT44T_C follow-up samples can be variable depending on the beef commodity to be sampled and may or may not require the cloth sampling technique. Specific instructions to IPP will be provided through District Office in coordination with Headquarters OFO subject matter experts, if needed, on a case-by-case basis for assigned MT44T_C sampling tasks.
8. Each positive result in a follow-up sampling set triggers another follow-up sampling set. PHIS automatically adds enough follow-up sampling tasks for IPP to collect the desired number of consecutive negatives to complete the follow-up sampling sets.
9. IIC should expect to receive a follow-up sampling set within 2 days of the positive sample result. If IPP do not receive the follow-up set within this timeframe, the IIC is to contact RMIS through the "Sampling" category of askFSIS to request a follow-up sampling set.
10. IPP are to contact RMIS through askFSIS if they have questions concerning sampling, including whether follow-up sampling sets have the appropriate project code and number planned, and what products to collect. IPP are also to contact RMIS before canceling a follow-up sampling task to determine whether canceling the follow-up sampling task is appropriate.
11. A PHIS alert informs IPP of the components to sample based on information in the database.
FOLLOW-UP SAMPLING AT SUPPLIERS
1. If the originating slaughter establishments supplied more than one type of source material used in the positive ground beef or bench trim sample, PHIS will generate sampling tasks for each type of source material.
2. IPP are to collect a single follow-up sample or multiple follow-up samples at supplier establishments as assigned. PHIS does not assign follow-up sampling tasks at establishments that only bone or fabricate beef primal or subprimal cuts but do not slaughter, except for ammoniated beef trimmings (see C.4. and 5. of this section), because supplier follow-up samples target the supplying slaughter establishment.
3. PHIS assigns 16 MT52_C follow-up sampling tasks for the originating slaughter establishment when:
  1. The originating slaughter establishment was the only supplier, or,
  2. Any of the originating slaughter establishment were suppliers that had previously been identified in STEPS within approximately 4 months (120 days) of the current raw ground product or bench trim positive result.
4. PHIS assigns 8 MT52_C follow-up sampling tasks for the originating slaughter establishments in response to an AMS positive or if the establishment produces less than 1,000 pounds per day of the product that tested positive.
5. The follow-up samples are identified for each component used in the positive raw ground beef or bench trim product.
  1. If a supplier is not a sole supplier or a repeat supplier in STEPS, PHIS assigns a single follow- up sampling task for the supplier for each component used in the positive raw ground beef or bench trim product.
  2. In the event of an AMS positive STEC raw ground beef sample result under the AMS commodity purchase program, PHIS assigns 8 MT52_C follow-up sampling tasks to the originating slaughter establishments. IPP are to collect follow-up samples of the requested source materials used to produce the ground product AMS found positive until 8 consecutive negative samples are received, regardless of establishment size in response to an AMS positive result.
  3. In combination slaughter/processing establishments, if a Federal agency other than FSIS or a State entity finds ground product positive, and the results are accepted by FSIS, PHIS assigns MT53 sampling tasks to the combination slaughter/processing establishment that produced the source material.
    1. IPP are to collect either 8 or 16 MT53_C samples, based on establishment size and the type of source materials used in the positive raw ground beef product.
    2. IPP are not to collect follow-up samples of raw ground beef product.
    NOTE: Follow-up samples of raw ground beef product are to be collected from the grinders that used purchased source materials (see Section I. F.1 of this chapter).
  4. If ammoniated low-temperature-rendered (LTR) product was used as a component in raw ground beef products that tested positive for STEC when sampled by FSIS or another Federal or State entity, PHIS assigns MT53_C sampling tasks. IPP are to collect MT53_C samples of ammoniated boneless lean beef tissue at the establishment that produced the ammoniated LTR product, even if that establishment is not an originating slaughter establishment.
  5. If the establishment that produced the ammoniated LTR is not an originating supplying slaughter establishment, PHIS does not request MT52_C sampling tasks at the slaughter establishments that produced the source materials used in the ammoniated LTR, except as provided in the D.3 of this Section.
6. If the ammoniated LTR product tests positive under the MT53_C verification sampling program:
  1. IPP are to collect supplier information from the establishment that produced the ammoniated low-temperature rendered product.
  2. The DO is to enter the supplying establishments into STEPS.
  3. PHIS assigns MT52_C sampling tasks the slaughter establishments that produced the source materials used in the positive ammoniated LTR product.
SPECIAL INSTRUCTIONS FOR FOLLOW-UP SAMPLING (MT52_C) OF INTACT BEEF COMPONENTS THAT WERE NOT INTENDED FOR USE IN RAW NON-INTACT PRODUCT
1. If intact product was used as a component in raw ground beef product or was sampled as bench trim that FSIS finds positive for STEC, IPP are to select a carcass (rather than the component of the carcass) at the originating slaughter establishment for follow-up sampling under the following conditions:
  1. HACCP plan records and purchase specification records for product produced at the originating slaughter establishment show that the intact product was not intended for grinding or non-intact product, and that the establishment informed purchasers that the product was not intended for grinding; and
  2. The establishment derived intact product from the carcass in a manner to minimize commingling with other product, and the establishment packaged the product separately from other product without commingling (e.g., boneless chucks were placed on a conveyor belt and were then off-loaded for packaging without being commingled with other product).
2. IPP are to verify that that the conditions in A. are met. If the conditions in A. are met, IPP are to collect the samples at the originating slaughter establishment from one or more carcasses hanging in the cooler before fabrication.
  1. IPP are to contact the District Office through their supervisory chain-of-command to obtain the most up-to-date sampling procedure for follow-up sampling of carcasses.
  2. The District Office is to contact HQ OFO subject matter expert when sampling instructions are requested.
  3. IPP are not to wait until the establishment breaks the carcass down into primal and subprimal cuts to collect follow-up samples.
3. If both conditions in A. are not met, IPP are to sample the intact components that were used to produce the positive raw ground beef or bench trim products using the cloth sampling method.
4. If the FSIS sample collected is positive in B., generally only the sampled carcass is implicated because STEC contamination is generally point-source contamination that occurs sporadically as a consequence of handling during hide removal and dressing of the carcass. However, if the establishment does not prevent carcasses from being commingled or does not have adequate controls to prevent cross-contamination among carcasses, it will not be able to designate a single carcass lot for sampling.
  1. The establishment may decide to destroy the implicated carcass or to use it to produce products that will be processed to destroy the pathogen (e.g., by cooking).
  2. Because establishments remove the head and cheek meat, weasand, hearts, or offal during the slaughter process and process them separately from the rest of the carcass, FSIS will not consider these parts associated with the positive STEC result, unless there is cross- contamination, inadequate sanitary dressing procedures, or inadequate controls to prevent contamination.

CHAPTER VIII- SAMPLING OF RAW BEEF PRODUCT INTENDED FOR THE NATIONAL SCHOOL LUNCH PROGRAM (NSLP)

GENERAL
Establishments may produce product for the NSLP, which is administered by the Food and Nutrition Service (FNS). AMS is responsible for testing product under the NSLP.
IPP VERIFICATION RESPONSIBILITIES;
1. IPP verify that establishments adequately address adulterant STEC by collecting samples at establishments that produce raw beef product for the NSLP, even if the establishment collects a sample to be tested for the AMS program.
  1. When IPP receive a sampling task at an establishment that produces product for both the NSLP and other further processors, IPP are to prioritize sampling the non-NSLP product, if available. If only NSLP product is available during the sampling window, IPP are to collect samples from NSLP product.
  2. When an establishment produces raw non-intact beef or raw intact beef intended for non-intact use for the NSLP only, IPP are to collect samples as requested. In this situation, IPP are to collect the sample even if the establishment is collecting a sample from the same production lot for AMS testing for the NSLP.
2. IPP are to review Table 7 (below) and use the information to help them determine when to collect samples under the NSLP.
3. When a sample collected under the NSLP tests positive, IPP are to collect product for follow-up sampling from either NSLP product or other product. IPP are not to prioritize sampling products for other customers over NSLP product.
  
  NOTE: Samples also collected for NSLP tests cannot be substituted for those collected by FSIS for follow-up sampling.
4. When a sample collected under the NSLP tests positive, IPP are to collect 8 follow-up samples even in high volume establishments, because the product is already subject to AMS sampling requirements.
5. IPP are responsible for verifying corrective actions for a positive result for either the FSIS sample or a sample collected by the establishment for AMS testing, including appropriate disposition of the product. A positive result from either sample would mean product is adulterated, and IPP are to follow instructions regarding positive sample results.
DO RESPONSIBILITIES IN RESPONSE TO AN AMS CONFIRMED POSITIVE TEST RESULT
The DO is to follow the instructions provided in Chapter VI of this directive.

CHAPTER IX- IMPORTS SAMPLING

DEFINITIONS FOR IMPORT SAMPLING
1. PHIS makes sampling assignments for STEC based on the shipment data (process category, product category, product group) entered into PHIS. The three levels of reinspection (LOR) assigned to a type of inspection (TOI) by PHIS are Normal, Increased, and Intensified.
2. The sampling projects for imported product tested for STEC are:
  1. MT08 - the TOI and sample project for the STEC (E. coli O157:H7 and non O157 serogroups) in imported raw ground beef (including veal) product. Assigned at Normal, Increased or Intensified LOR.
  2. MT51 - the TOI and sample project for the STEC in imported raw beef manufacturing trimmings in other raw ground beef components. Assigned at Normal, Increased or Intensified LOR.
3. Imported raw beef product collected for STEC analysis under the MT08 and MT51 sampling programs will also be analyzed for Salmonella.
GENERAL RAW BEEF PRODUCT SAMPLING CONDUCTED AT IMPORT ESTABLISHMENTS
1. STEC Sampling of Imported Raw Beef Products Video training is available online.
2. IPP Help provides sample collection procedures for N60 sampling of MT51 imported frozen beef manufacturing trimmings and other frozen components.
3. When PHIS assigns an E. coli O157:H7 TOI for STEC analysis to a lot of imported product, import inspection personnel are to:
  1. Notify the import establishment management of the reason for collecting a sample for STEC testing (normal, increased, or intensified LOR);
  2. Follow the sampling instructions for the appropriate project;
  3. When applicable, inquire whether the Importer of Record (IOR) will be holding the lot on-site t the official import inspection establishment or off-site under the IOR's control. When the lot will be held off-site, import inspection personnel are to record the location in the Remarks block of the Sample Collection - Sample Management page in the PHIS; and
  4. Collect samples from one specific production code or date.
4. In PHIS import inspection personnel are to:
  1. From the Lab TOIs screen, click on Sample Form box. The Sample Management - Sample Collection page will appear, with the Generate a Sample tab open.
    
    NOTE: In the rare event that the sample was already submitted to the lab on a non-PHIS issued form because PHIS was down during intensified or increased LOR, and import inspection personnel submitted the sample outside of PHIS, import inspection personnel are to place a check in the "Has this sample already been mailed to the lab using a non-PHIS form?" box before proceeding.
  2. Verify the information on the screen is correct. If the information is not correct, make the corrections before proceeding.
  3. Check the appropriate "Analyses" boxes for Salmonella and E.coli O157:H7 & Non-O157 STEC for the assigned TOI:
    1. STEC MT08; and
    2. STEC MT51: (Boneless Manufacturing Trimmings and Other than Boneless Manufacturing Trimmings).
  4. Enter the appropriate sample weight and save the information.
  5. After opening the Sample Collection Data tab, complete the required fields.
  6. For the Production Date field, if the product code is a calendar date, select the date. If the code is not a calendar date, import inspection personnel are to type "Product Code:" in the "Remarks" block on the Sample Collection Data tab, followed by the product code, and select today's date for the Production Date field.
  7. In the Remarks block, enter any additional information that may be helpful to the lab. When the lot will be held off-site until the laboratory results are reported, import inspection personnel are to enter the name and address of the location where the IOR indicates the lot will be held. Select Save & Continue.
  8. After opening the Additional Info tab opens, click on "Take Questionnaire" and, if prompted, save changes.
  9. To complete and save the questionnaire, follow the on-screen prompts that appear.
  10. Return to the Lab Sampling screen Data Collection Tab and select "Print Form." Review the on-line form and, if accurate, print it.
  11. Prior to clicking "Submit to Lab", enter their title and the date, and then submit to lab.
5. Import inspection personnel are to access the Laboratory Information Management System (LIMS-Direct) to retrieve the laboratory results and provide the results to import establishment management even if the establishment receives e-mail notifications.
6. Import inspection personnel are to access PHIS to verify the results have posted to the lot in PHIS. If results do not post into PHIS within 48 hours, import inspection personnel are to submit a Client Experience Center (CED) ticket.
7. Import inspection personnel are to not perform the TOI in PHIS when notified that a laboratory sample from a lot held under an IOR's control has been discarded and will not be analyzed by the FSIS laboratory. Import inspection personnel are to notify the official import inspection establishment so the IOR can release the product.
8. Import inspection personnel are to access PHIS to submit a second sample when notified that a laboratory sample from a lot held under FSIS control has been discarded and will not be analyzed by the FSIS laboratory. Import inspection personnel are to notify the official import inspection establishment so it can notify the IOR that the lot will continue to be on hold until sample results for the second sample are reported.
9. Import inspection personnel are to submit a completed FSIS Form 9770-3, "Discarded Sample Report and Findings" for samples that the FSIS laboratory reports as discards to the supervisor after completion. Import inspection personnel assigned to the import establishment from which the sample was sent are to complete the form.
10. Import inspection personnel are to initiate a refused entry in PHIS for the sampled lot if the sample reports as positive. If the lot was held off-premises, import inspection personnel are to notify import establishment management to request that the IOR return the product to the official import inspection establishment for marking and disposition. EXCEPTION: if the shipment is from Canada and was returned to Canada under the Annex J procedures referenced in FSIS Directive 9900.6, Laboratory Sampling Program for Imported Meat, Poultry, and Egg Products, the shipment does not need to be returned for marking and disposition. IPP are to report the results for product returned to Canada following the procedures in FSIS Directive 9900.6 .
11. Import inspection personnel are to notify their supervisor immediately if they become aware that the IOR has not held the lot and has moved it into commerce.
12. Import inspection personnel are to verify the marking and disposition of the lot for refused entry lots, as per FSIS Directive 9900.8, Meat, Poultry, Egg Products, and Shell Eggs Refused Entry into the United States (U.S.).
SAMPLING PROGRAM FOR IMPORTED BEEF MANUFACTUCTURING TRIMMINGS AND OTHER COMPONENTS (MT51)
1. Product sampled under the MT51 sampling program at official import inspection establishments may contain both beef manufacturing trimmings and other components (such as cheek meat, head meat, or other components described in this directive). Sampled lots are to be tested for STEC and Salmonella.
2. For beef manufacturing trimmings and other raw ground beef components - Fresh (not frozen), import inspection personnel are to follow the N60 excision method described in Chapter V Section IV.
3. To sample frozen (or fresh) beef manufacturing trimmings and other raw ground beef components, import inspection personnel are to select 5 containers from the lot. The containers are to have the same production code or date. Import inspection personnel are to collect 60 individual pieces from frozen beef manufacturing trimmings and other raw ground beef components as described in the MT51 sampling procedure in Attachment 5 and on IPP help-raw beef sampling.
OBTAINING SAMPLE RESULTS
Import inspection personnel are to access LIMS-Direct for sample results as described for domestic samples.
ACTIONS TO TAKE BASED ON RESULTS
1. When a sample tests negative for STEC, the sampled lot is not subject to further testing, and import inspection personnel are to release it if it is on FSIS hold, and all other reinspection criteria are acceptable.
2. Presumptive positive
  1. When LIMS-Biological Information Transfer and E-mail System (BITES) notifies Office of Field Operations (OFO) import inspection management (headquarters and supervisor) that a sample is presumptive positive, the supervisor is to notify import inspection personnel that the sample has a presumptive positive status. OFO Recall Management Technical Analysis Division (RMTAD) -Imports Headquarters staff is to follow the instructions provided in FSIS Directive 10010.3.
  2. Import inspection personnel are to:
    1. Notify establishment management of the presumptive positive result and report whether the lot is on hold by the IOR or FSIS and the location of the lot to their supervisor;
    2. Provide the supervisor with a copy of the health certificate and any other documents pertinent to the lot, including copies of the FSIS form 9540-1 and laboratory form which may be printed from PHIS;
    3. If the lot is on an IOR hold, inform import establishment management that import inspection personnel are placing the product on FSIS hold. Import inspection personnel are to request that import establishment management contact the IOR to inform it of the presumptive positive, and that the product is on FSIS hold. Import inspection personnel are to report to their supervisor that the product is on FSIS hold;
    4. If the lot is not on FSIS hold but is still at the import establishment, import inspection personnel are to retain the product and request import establishment management to contact the IOR to inform it of the presumptive positive result and the retention of the product. Import inspection personnel are to report to their supervisor that the product is being retained;
    5. If the lot is on an IOR hold and has been moved from the official inspection establishment to an off-site location, request import establishment management to:
      1. Contact the IOR to inform it of the presumptive positive;
      2. Inform the IOR that import inspection personnel are placing the product on FSIS hold and to stop further movement of the product; and
      3. Request the off-site location of the product. Import inspection personnel are to report the location information to their supervisor.
    6. OFO Headquarters is to notify the inspection program officials of the involved exporting country as soon as an Agency laboratory reports a presumptive positive result in order to identify whether the establishment from the exporting country has any other product from the presumptive positive lot identified in the United States.
3. Confirmed positive results
  1. When a sample is confirmed positive for any adulterant STEC, import inspection personnel are to:
    1. For a lot initially on hold by the IOR, initiate a refused entry in PHIS for the sampled lot. If the lot was being held off-premises, request import establishment management contact the IOR to inform it of the positive result and request that the lot be returned to the official import inspection establishment as soon as possible.
    2. For a lot initially on FSIS hold, initiate a refused entry in the PHIS. Import inspection personnel are to follow the refused entry procedures identified in FSIS Directive 9900.8; and
    3. Contact their supervisor who is to contact RMTAD to initiate a recall if the lot was moved into commerce.
  2. OFO import inspection Headquarters staff are to notify the inspection program officials of the involved exporting country, through the FSIS Office of International Coordination (OIC), as soon as a laboratory reports a positive result in order to identify whether the foreign country has any other production lots from the lot identified exported to the United States. If any lots are identified by the foreign country from the same producer with the same production code, OFO is to:
    1. Request a recall of the product if import inspection personnel passed the product under import reinspection; and
    2. Refuse entry of the product if import inspection personnel have not passed the product under import reinspection.
  3. OFO import inspection Headquarters is to issue an alert to import inspection personnel to refuse entry for the same lot of product with the same production codes that the foreign country presents for FSIS import reinspection after the confirmed positive result and, if needed, direct import personnel to take additional action.
4. If the product represented by the same production codes or dates that tested positive for an adulterant STEC moved into commerce by the IOR, then:
  1. Import inspection personnel are to send a completed copy of FSIS Form 9540-1 and the foreign health certificate via fax (202) 720-6050 to the OFO import inspection Headquarters.
  2. OFO import inspection Headquarters is to notify, through the FSIS, OIC, the head of the inspection service in the country of origin and the Foreign Agriculture Service (FAS) representative to the country from which the positive product arrived of the confirmed positive adulterant STEC sample result. OFO import inspection Headquarters is also to inform them whether FSIS will request that the IOR recall any of the applicable product in commerce. OFO import inspection Headquarters is to request that the foreign country conduct an FSA or equivalent procedure at the producing establishment and test follow-up samples from the grinding facility or the originating slaughter establishments that produced the positive product.
    
    EXAMPLE: Raw beef product was imported from a single lot but as two separate shipments with different shipping marks. FSIS only tested one of the shipments, found it positive, and refused entry to the shipment. The products that FSIS sampled and released were in cold storage and so were not distributed. The company wanted to move that product to an official establishment for a lethality treatment. There is no HACCP plan or pre-shipment review associated with the now domestic product. The product in this example would need to move only under FSIS seal because there is not a supplying domestic establishment to control the product per the instructions in this directive.

CHAPTER X - DATA ANALYSIS

Members of the Office of Public Health Science will report the FSIS STEC laboratory test results for raw ground beef products, trim, and other raw ground beef components on FSIS's website. Members of OPARM will compute annual prevalence estimates of adulterant STEC in raw ground beef and beef manufacturing trimmings.

CHAPTER XI - QUESTIONS

Refer questions regarding this directive to your immediate supervisor or as needed to the Risk Management and Innovations Staff through askFSIS select Sampling as the Inquiry type or contact askFSIS by telephone at 1-800-233-3935.

NOTE: Refer to FSIS Directive 5620.1, Using askFSIS, for additional information on submitting questions.

Food Safety and Inspection Service