CHAPTER I – GENERAL

I. PURPOSE

This directive provides instructions to inspection program personnel (IPP) on the verification activities, other than FSIS sampling, related to Escherichia coli O157:H7 (E. coli O157:H7) and non-O157 Shiga toxin-producing E. coli (STEC). FSIS is reissuing this directive to reflect current policy regarding the importation and movement of product through Federal establishments bearing instructional statements concerning STEC, in Chapter IV Sections V and VI. These instructions were previously included in FSIS notices. FSIS is also updating the directive to provide additional information on reassessment requirements when establishments have produced product found positive for STEC.

KEY POINTS:

• IPP verify HACCP regulatory requirements in establishments that produce raw beef products by performing the HACCP verification task and the Hazard Analysis Verification (HAV) task
• FSIS verification activities for raw beef products include raw veal products
• IPP at import establishments are to follow the instructions in Chapter IV Section V when verifying instructional statement

II. CANCELLATIONS

FSIS Directive 10,010.2 Verification Activities for Shiga Toxin-Producing Escherichia Coli (STEC) in Raw Beef Products, 08/20/15

Notice 19-19, Label Verification of Imported Raw Beef Products Labeled “For Cooking Only” or “For Full Lethality Treatment”, 06/19/19

III. BACKGROUND

A. FSIS considers all raw non-intact beef and raw intact beef intended for use in raw non-intact product to be adulterated under the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601(m)(1)) when it is contaminated with an adulterant, including E. coli O157:H7 and these six non-O157 STEC when the Shiga toxin (stx) and Intimin (eae) genes are present: O26, O45, O103, O111, O121, and O145.

B. STEC contamination is a food safety hazard that is reasonably likely to occur during the slaughter and processing of raw intact and raw non-intact beef products. The establishment may use a multi-hurdle approach and incorporate multiple controls and preventive measures to address this hazard in its HACCP system. Thus, the establishment may control the pathogen through one or more critical control points (CCPs) in its HACCP plan or prevent the potential pathogen from occurring through preventive measures in its Sanitation Standard Operating Procedures (Sanitation SOPs), through other prerequisite programs, or a combination of these mechanisms.

C. IPP are to be aware that establishments producing raw beef product need to effectively address the hazard. At this time, there are few controls specific to non-O157 STEC that are not also effective against E. coli O157:H7. However, an establishment may determine that its controls or preventive measures for E. coli O157:H7 effectively control or prevent non-O157 STEC. Interventions validated to control E. coli O157:H7 should be effective in controlling the non-O157 STECs when properly implemented as described in the establishment’s supporting documentation.

CHAPTER II – IPP HACCP VERIFICATION ACTIVITIES

I. GENERAL

IPP are to verify that establishments that produce raw intact and non-intact beef products meet HACCP regulatory requirements by performing HAV Tasks and HACCP Verification Tasks.

II. PERFORMING THE HAV TASK

IPP are to use the questions in Table 1 when performing Raw Intact and Raw Non-Intact HAV Tasks in addition to the instructions in FSIS Directive 5000.6 Performance of the HAV Task.

TABLE 1: QUESTIONS TO CONSIDER WHEN PERFORMING THE HAV TASK IN RAW INTACT AND RAW NON-INTACT BEEF PRODUCTS

III. PERFORMING THE HACCP VERIFICATION TASK

IPP are to use the instructions provided in FSIS Directive 5000.1, Verifying an Establishment’s Food Safety System, and the information in Table 2 when performing Raw Intact and Raw Non-Intact HACCP Verification Tasks.

TABLE 2: INFORMATION TO CONSIDER WHEN PERFORMING THE HACCP VERIFICATION TASK IN RAW INTACT AND RAW NON-INTACT BEEF PRODUCTS

CHAPTER III – IPP RESPONSIBILITIES RELATED TO POSITIVE STEC SAMPLE RESULTS

I. IPP RESPONSIBILITIES WHEN AN ESTABLISHMENT RECEIVES A POSITIVE STEC SAMPLE RESULT FROM FSIS, ANOTHER FEDERAL ENTITY, OR STATE

A. Verify the corrective action requirements (Step 5 in Table 2):

1. IPP are to verify that products found positive for STEC from FSIS or establishment testing receive appropriate disposition.

2. IPP are to verify that the establishment transporting presumptive positive or positive product to another site for appropriate disposition has met all corrective action requirements by verifying that the establishment maintained:

a. Records identifying the official establishment, renderer, or landfill operation that received presumptive positive or positive product;

b. Control of product that was destined for a landfill operation or renderer while the product was in transit (e.g., through company seals);

c. Control of product that was destined for an official establishment while the product was in transit (e.g., through company seals) or ensured that such product moved under FSIS control (e.g., under USDA seal or accompanied by FSIS Form 7350-1). IPP are to be aware that use of the instructional statement “For Cooking Only” statement is not sufficient control; and

d. Records showing that presumptive positive or positive product received the proper disposition, including documentation showing proper disposal of the product from the official establishment, renderer, or landfill operation where disposition occurred.

3. If the positive product is shipped to another official establishment for disposition (e.g., for cooking), IPP at the receiving establishment are to verify that it adequately addresses the pathogen in the product. Specifically, IPP are to verify that the receiving establishment:

a. Documents the receipt of presumptive positive or positive product, as required under 9 CFR 417.5;

b. Maintains control of the product; and

c. Addresses the receipt of STEC- positive product in its hazard analysis, flow chart, and HACCP plan, so that the positive product will receive an adequate lethality treatment to destroy the pathogen.

4. If an establishment ships adulterated product to a renderer or landfill operation, IPP are to routinely verify the establishment denatures the product before the product leaves the establishment (9 CFR 314.3).

a. There may be situations when an establishment may want to move product to a renderer or landfill without denaturing the product before the product leaves the establishment;

b. In these situations, the establishment must put the request in writing, describe the controls it uses in its request, and obtain permission from the D.O.;

c. IPP are to verify that the establishment follows the procedures agreed upon with the D.O.; and

d. If IPP find noncompliance with 9 CFR 314.3, they are to document it in accordance with FSIS Directive 5000.1. In situations where the establishment has not properly moved the product, IPP also are to notify the D.O. through supervisory channels.

5. Generally, an establishment may not ship positive or presumptive positive product through a cold storage facility because the establishment that produced the product must maintain control of it during shipment. Control is typically lost once the cold storage facility takes ownership of the product (see Section VI). However, there may be circumstances in which either the producing or receiving establishment can ship positive or presumptive positive product through a cold storage facility. In this situation, IPP are to verify that the producing establishment maintains:

a. Control of the product while it is in transit (e.g., through company seals) or ensure such product moves under FSIS control (e.g., under USDA seal or accompanied by FSIS Form 7350-1);

b. Records identifying the cold storage facility and how the products will be controlled while stored in the cold storage facility;

c. Records identifying the official establishment, renderer, or landfill that received the product; and d. Records that show that the product received proper disposition, including documentation evidencing proper disposal of the product from the official establishment where disposition occurred or from the renderer or landfill where disposition occurred.

6. When verifying the adequacy of corrective actions in response to a non-O157 STEC positive from FSIS testing, IPP are to first determine whether the establishment identified non-O157 STEC as a hazard in its hazard analysis.

a. If the establishment identified non-O157 STEC in its hazard analysis, IPP are to verify that the establishment takes corrective action in accordance with 9 CFR 417.3(a).

b. If the establishment did not identify non-O157 STEC in its hazard analysis or does not have controls for E. coli O157:H7 that would also address non-O157 STEC, IPP are to verify the establishment:

1. Performs reassessment to determine whether the newly-identified deviation or other unforeseen hazard should be incorporated into the HACCP plan, per 9 CFR 417.3(b)(4);

2. Documents the reasons for any changes to the HACCP plan based on the reassessment, or the reasons for not changing the HACCP plan based on the reassessment, per 9 CFR 417.4(a)(3)(ii); and

3. Provides all supporting documentation, including support for the decisions made during reassessment, per 9 CFR 417.5(a)(1).

c. IPP are to question whether the design or implementation of the establishment’s unique food safety system is sufficient to control STEC when non-O157 STEC contamination is identified in the production process even though the E. coli O157:H7 results and other processing CCP records may indicate process control was maintained.

d. In response to one or more non-O157 STEC positives, IPP are to verify whether any additional establishment testing conducted includes non-O157 STEC as part of the validation, verification and reassessment requirements of 9 CFR 417.4  and supporting documentation requirements of 9 CFR 417.5(a)(1), until the establishment is able to demonstrate control over STEC in their unique HACCP system, or the HACCP system may be deemed inadequate (9 CFR 417.6).

B. Determining and documenting noncompliance:

1. IPP are to document a noncompliance record (NR) for the confirmed positive result from FSIS testing, as described below and as instructed in FSIS Directive 5000.1.

a. If FSIS finds the product to be positive for non-O157 STEC or E. coli O157:H7, and the establishment also tested the product, IPP are to check establishment test results to determine whether the establishment also found the sampled product positive for E. coli O157:H7 or non-O157 STEC.

i. If FSIS finds the product positive, and the establishment testing found that the product was negative (or the establishment did not perform testing), then IPP are to issue an NR (citing 9 CFR 301.2 and 9 CFR 9 CFR 417.4(a)) because the establishment’s HACCP system did not identify the adulterated product being produced.

ii. IPP are to issue an NR to establishments that have a written program to divert all product that FSIS samples to cooking unless the establishment also tested the product and found it positive for STEC.

2. IPP are not to issue an NR in response to the positive FSIS result if both of the following are true:

a. The establishment held the product or maintained control of the product (e.g., the establishment moved the product off-site but did not complete pre-shipment review or transfer ownership of the product to another entity) pending its own test results; and

b. FSIS and the establishment both found the product positive for either E. coli O157:H7 or non-O157 STEC. FSIS testing and establishment testing do not have to identify the exact same adulterant STEC serogroup as long as both testing results have identified the sample as STEC positive.

3. If IPP find that the establishment did not hold or maintain control of the product, he or she is to issue an 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 (Step 6 in Table 2) following availability of all relevant test results, as set out in 9 CFR 417.5(c). IPP are to immediately contact the DO. If the results are confirmed positive for STEC, the DO is to take appropriate administrative action and contact the Recall Management and Technical Analysis Division (RMTAD) and Office of Investigation, Enforcement and Audit, Compliance and Investigation Division (CID), Regional Director (RD). As appropriate, FSIS will request a recall or detain the product. The CID RD, in consultation with Headquarters, will consider whether additional enforcement actions or sanctions are necessary.

4. IPP are to verify, after the establishment has implemented its corrective action, that the establishment implements corrective actions that meet the applicable requirements in 9 CFR 417.3, including ensuring the product receives appropriate disposition (Step 5 in Table 2).

5. For FSIS positive results from follow-up samples from raw non-intact products and raw intact products intended for raw non-intact use, IPP are to:

a. Associate noncompliance (e.g., previous FSIS STEC positive results, sanitary dressing, antimicrobial intervention implementation), as appropriate; and

b. Cite 9 CFR 417.3(a) on the NR because the establishment’s corrective actions were not implemented or not effective (i.e., failed to prevent the recurrence of a positive result). 6. If IPP have concerns about the adequacy of the HACCP system, they are to discuss their concerns with their supervisors.

II. IPP RESPONSIBILITIES WHEN AN ESTABLISHMENT HAS A POSITIVE STEC SAMPLE RESULT FROM ITS OWN TESTING

A. When performing the HACCP verification task (Step 3 in Table 2), IPP are to review the records associated with any STEC testing conducted by an establishment (see FSIS Directive 5000.2 Review of Establishment Testing Data by Inspection Program Personnel). If IPP find presumptive positive or confirmed positive STEC results in the testing records, they are to verify that the establishment is implementing corrective actions (Step 5 in Table 2). When an establishment tests product, a presumptive positive or positive result alone does not warrant an NR. IPP are only to issue an NR in response to an establishment’s presumptive positive or positive finding if the establishment fails to take the appropriate actions in accordance with its HACCP system to meet the requirements in 9 CFR 417.3.

B. If an establishment is only performing screening tests (e.g., a presumptive positive) and does not follow up with additional testing to determine whether STEC is isolated from the product, IPP are to verify that the establishment addresses the product as if it had tested positive. The establishment cannot use negative results from a second screening test for STEC to support food safety because a screening test is not a conclusive (specific) test for the pathogen.

C. When performing a HACCP verification task (Step 3 in Table 2), IPP are to verify that establishment employees conducting sampling for STEC do not sample sterile product that could not be contaminated with STEC (e.g., product taken from the interior of a muscle). If IPP observe such sampling, they are to document noncompliance with 9 CFR 417.4(a)(2) on an NR in accordance with the instructions in FSIS Directive 5000.1.

D. IPP are to be aware that STEC positives occur on an infrequent basis, (i.e., typically less than 1%). When an establishment conducts frequent testing and never finds a positive, IPP are to notify their Supervisor and D.O. as this may indicate problems with the validity of the sampling and testing methodology. When an establishment conducts frequent testing and frequently finds STEC positives, including numerous positives within a day or week, IPP are to notify their supervisor and D.O. as the results may indicate the establishment is not maintaining process control. In these situations, the D.O. may schedule an Enforcement, Investigations and Analysis Officer (EIAO) to review the establishment’s STEC control and verification measures.

III. ESTABLISHMENTS CONDUCTING PRE-SHIPMENT REVIEW FOR PRODUCT THAT IS NOT AT THE PRODUCING ESTABLISHMENT

When performing a HACCP verification task (Step 6 in Table 2), IPP are to be aware that Agency policy allows establishments to conduct pre-shipment review when the product is at locations other than at the producing establishment, provided the product does not leave the control of the producing establishment. Some establishments analyze samples for STEC while they are moving the product, but the product is still under the establishment’s control. IPP are to be aware that the Agency provides establishments the flexibility to move their product before pre-shipment review when the establishment is conducting testing for STEC and maintains control of the product (e.g., through company seals or FSIS control).

CHAPTER IV – VERIFICATION PROCEDURES INVOLVING INSTRUCTIONAL OR DISCLAIMER STATEMENTS CONCERNING STEC

I. GENERAL

This chapter provides instructions for IPP for verifying an establishment’s use of instructional or disclaimer statements during HACCP verification and HAV tasks.

NOTE: See Attachments 2 and 3 for corresponding flow charts.

II. INSTRUCTIONAL OR DISCLAIMER STATEMENTS CONCERNING STEC

A. An instructional statement concerning STEC is a statement that addresses how the product is to be prepared or handled to ensure that the pathogen is eliminated or reduced to below detectable levels. If an official establishment labels product with the phrase “for further processing” without further qualification, this phrase is not an instructional statement. It is a statement of limited use.

1. Examples of instructional statements concerning STEC in raw ground beef components, raw beef patty components, and raw ground beef products may include, “for full lethality treatment,” “for cooking only,” or “for further processing into ready-to-eat (RTE) products that will receive a full lethality treatment.”

a. Cooking is applying heat to a product at a sufficient temperature and for a sufficient period of time to eliminate STEC.

b. Full lethality treatment may be cooking or another process that eliminates STEC, such as fermentation or salt curing.

B. A disclaimer statement, concerning E. coli O157:H7, is a statement regarding the type of verification activities addressing the pathogen that were not used in the production of the product. An example of a disclaimer statement concerning E. coli O157:H7, is “product has not been tested for E. coli O157:H7.”

C. Product bearing instructional or disclaimer statements are not to be offered for export, sent to stateinspected establishments or sent to retail exempt firms, including hotels, restaurants, or institutions (HRI).

D. A statement that the establishment does not intend to use the product in ground product or other nonintact product is not an instructional or disclaimer statement (e.g., “not intended for grinding” or “not intended for raw ground”). These types of statements may not be used at all on product labels. If IPP observe the use of the above statements, they are to notify the D.O. through their supervisory chain-of-command.

III. PRODUCTS BEARING INSTRUCTIONAL OR DISCLAIMER STATEMENTS CONCERNING STEC

A. IPP are to be aware that establishments can only place these statements on product for use at other official establishments, and that these statements require prior approval by the Office of Policy and Program Development (OPPD), Labeling and Program Delivery Staff (LPDS). As a condition of label approval, LPDS specifies that establishments can only use such statements on products destined for official establishments that ensure that these products receive adequate lethality treatment.

B. When conducting a General Labeling task, IPP are to verify that the establishment has received prior approval from LPDS. If IPP find that the establishment does not have prior approval, IPP are to document noncompliance on an NR and cite 9 CFR 412.1(a).

C. When performing a HACCP verification task (Step 6 in Table 2), IPP are to verify that the product that bears an instructional statement is only being sent to an official establishment for further processing.

D. When performing a HACCP verification task (Step 5 in Table 2), IPP are to be aware that establishments may label product with instructional statements (e.g., “for cooking only”) if the establishment has not tested the product for STEC.

E. IPP are to be aware that positive product can bear instructional statements. However, an instructional or disclaimer statement is not sufficient control for movement of positive product. The establishment is required to move product under controls and maintain records showing that the product received proper disposition (see Chapter III, Section I.A.2.)

F. Establishments’ use of instructional or disclaimer statements is optional.

IV. VERIFICATION ACTIVITES AT ESTABLISHMENTS THAT APPLY INSTRUCTIONAL OR DISCLAIMER STATEMENTS

A. When performing a HAV task, IPP are to verify that:

1. The instructional or disclaimer statement is not being used as a control or CCP to address STEC;

2. The establishment is not using an instructional or disclaimer statement to justify its determination that STEC is not a hazard reasonably likely to occur in the production of these products; and

3. The establishment’s HACCP plan for products that bear a disclaimer statement includes a validated intervention for STEC. A disclaimer statement that indicates that the product has not been tested for STEC implies that the pathogen may be a food safety hazard reasonably likely to occur in the product in the absence of adequate controls. Therefore, the information contained in the disclaimer statement would be inconsistent with a determination in the hazard analysis that it is unnecessary to address STEC in the HACCP plan. In this situation, the HACCP plan may be determined inadequate (9 CFR 417.6).

B. If the establishment places a “for cooking only” or “for full lethality treatment” statement on the product and ships it to outside establishments, IPP, while performing the HAV task, are to verify that the hazard analysis shows how the shipping establishment is ensuring that the product will be shipped to official establishments that cook it or that provide other full lethality treatments. IPP are to verify that the shipping establishment has controls in place to ensure that the product goes to establishments that cook it. The product may be further processed at other official establishments prior to being received at official cooking establishments if control is maintained by the original shipping establishment (see Section VI  of this chapter). If the shipping establishment also produces product that it does not intend for cooking, IPP are to verify that the establishment has controls in place to segregate product intended for cooking from product not intended for cooking.

C. If IPP find that the establishment’s use of instructional statements does not meet the criteria in Section IV. A.1., or 2., or that the establishment’s use of disclaimer statements does not meet the criteria in Section IV. A. 1., 2., or 3. of this chapter, they are to document the noncompliance on an NR as described in FSIS Directive 5000.1, Chapter V, using the appropriate HAV task and the appropriate regulatory citation (usually, 9 CFR 417.5(a)(1)).

D. If an establishment labels product with an instructional or disclaimer statement and does not maintain evidence that the product was sent to an official establishment for further processing to destroy the pathogen, IPP are to document the noncompliance on an NR. IPP are to initiate a regulatory control action (9 CFR 500.2(a)) if the product is still at the official establishment or contact the District Recall Officer (DRO) through supervisory channels. Noncompliance exists because the product is misbranded. IPP are to be aware that establishments can only place these statements on product for use at other official establishments where the establishment will treat the product in a way to address STEC.

V. VERIFICATION ACTIVITIES AT IMPORT ESTABLISHMENTS FOR PRODUCTS BEARING INSTRUCTIONAL OR DISCLAIMER STATEMENTS

A. This section provides instructions to IPP for conducting verification of imported raw beef products bearing the “For Cooking Only” or “For Full Lethality Treatment” instructional statement claims. This is applicable only to import reinspection of raw beef products certified to go to a Federal establishment that applies cooking or a full lethality treatment to eliminate STEC.

NOTE: These instructional statements can only be applied to raw beef testing negative for STEC or that is untested. Raw, non-intact beef and raw beef intended for non-intact use presented for importation and determined to be either positive or presumptive positive for STEC at the time it is offered for importation is adulterated and is not permitted entry into the United States (U.S.) (9 CFR 327).

B. IPP are to verify instructional statement label claims in accordance with Qualifiers, Claims, Grade or Declaration Concerns (Section VI, G) in FSIS Directive 9900.5, Label Verification of Imported Meat, Poultry, and Egg Products.

C. IPP are to verify instructional statement label claims for each lot presented, in accordance with FSIS Directive 9900.1, Imported Product Shipment Presentation.

D. Raw beef products bearing the “For Cooking Only” or “For Full Lethality Treatment” instructional statement claims can only be further processed in official establishments and cannot be exported, sent to State-inspected establishments, or enter commerce. These products can be shipped through ID Warehouses or official establishments, pending delivery to the official establishment which applies cooking or full lethality treatment to eliminate STEC.

NOTE: All instructional statement label claims must be evaluated by LPDS prior to use. The instructional statement claim is not a control for STEC and is not a control for movement of product.

E. IPP are to verify the instructional statement claims through review of supporting documentation provided by the importer and the intended destination as described in D. below. If IPP have concerns regarding label claims, IPP are to retain the lot, use the Lot Tracking function in the Public Health Information System (PHIS) to select “Place the lot on hold” and contact their Frontline Supervisor (FLS).

F. To verify that the lot is intended to be cooked or receive a full lethality treatment by an official establishment, IPP are to:

1. Review contracts, bills of lading, letters of guarantee, agreements or other supporting documentation from the importer of record indicating how the lot will be handled to ensure the lot will be cooked or receive full lethality treatment; and

2. Review the import inspection application (Form 9540-1) to determine the destination establishment name and number (the consignee) and verify the establishment conducts RTE processing in PHIS by reviewing the establishment’s PHIS profile.

G. In addition to the Label Verification Type of Inspection (TOI) result (Pass/Fail), IPP are to record the “For Cooking Only Claim” or “For Full Lethality Treatment Claim” in the remarks to track imported lots bearing these claims.

H. IPP are not to sample raw beef products labeled “For Cooking Only” or “For Full Lethality Treatment”. In accordance with FSIS Directive 9900.6 Laboratory Sampling Program for Imported Meat, Poultry, and Egg Products (Section VI, C), IPP are to request through PHIS not to perform a laboratory sample TOI assigned by PHIS, and are to select “Instructional Claim: Cook/Lethality at Federal Est.” as the reason.

VI. VERIFICATION ACTIVITIES AT PRODUCING AND INTERMEDIARY ESTABLISHMENTS FOR PRODUCTS BEARING INSTRUCTIONAL OR DISCLAIMER STATEMENTS A. VERIFICATION ACTIVITIES AT PRODUCING ESTABLISHMENTS

1. When conducting a HACCP verification task, IPP at an establishment that applies instructional statements are to follow the instructions in Chapter IV. They are to verify the producing establishment maintains and implements sanitation procedures to prevent cross-contamination. They are to also ensure records adequately demonstrate the product was sent to an official establishment for a full lethality process.

2. When IPP identify noncompliance, they are to document the noncompliance on an NR as described in FSIS Directive 5000.1, Chapter V, using the HACCP verification task and the appropriate regulatory citation (usually 9 CFR 417.5).

3. IPP are to be aware that product for export or HRI, or product sent to a state-inspected establishment or to a retail firm may not bear an instructional statement.

B. VERIFICATION ACTIVITIES AT INTERMEDIARY ESTABLISHMENTS

1. IPP are to be aware that products labeled with instructional statements may be produced and labeled at one establishment and undergo further processing (e.g., repackaging, grinding) at an intermediate, non-cooking official establishment prior to being sent to another official establishment for cooking or other full lethality treatment.

2. Intermediary establishments that receive product labeled with an instructional statement and further process the product may reapply (i.e., “carry forward”) the instructional statement without label approval. IPP at intermediary establishments that carry forward labeling of product with an instructional statement are to:

a. Follow the instructions in Chapter IV to verify the establishment is appropriately using the instructional statement. The HACCP system for establishments that carry forward the instructional statement do not need to include a validated intervention for STEC as the product is intended for cooking or other full lethality treatment;

b. Verify the establishment’s hazard analysis (9 CFR 417.2) and decision-making documents (9 CFR 417.5) meet the criteria in Chapter IV when performing the HACCP verification task;

c. Verify the establishment tracks and facilitates communication between the supplying establishments and receiving establishments to ensure records are available showing each lot of product was sent to an establishment for cooking or other full lethality treatment; and

d. IPP are to document noncompliance on an NR as described in FSIS Directive 5000.1, Chapter V, using the HACCP verification task and the appropriate regulatory citation (usually 9 CFR 417.5) when they find that the intermediate establishment has not met the criteria above.

VII. VERIFICATION ACTIVITIES AT IDENTIFICATION WAREHOUSES FOR PRODUCTS BEARING INSTRUCTIONAL OR DISCLAIMER STATEMENTS

A. If IPP observe breaking bulk packages or repackaging of product bearing instructional or disclaimer statements at an identification warehouse, they are to:

1. Contact the DO immediately through their FLS (see FSIS Directive 12,600.1, Voluntary Reimbursable Inspection Services); and
2. Detain the product as directed (see FSIS Directive 8410.1, Detention and Seizure).

NOTE: Failure of an identification warehouse to adhere to the provisions of its application for service could result in the District Manager withdrawing that service (see FSIS Directive 12,600.1).

VII. VERIFICATION ACTIVITIES AT COOKING AND FULL LETHALITY TREATMENT ESTABLISHMENTS

A. When performing a HACCP verification task to verify that the HACCP requirements are met for incoming products with an instructional or disclaimer statement, IPP are to verify that an establishment that receives such incoming products:

1. Has addressed the use of incoming product with disclaimer statements in its HACCP plans as if the products may be contaminated with STEC; or
2. Is following any instructional statements on the incoming products as well, cooking product to a sufficient temperature and for a sufficient period of time to eliminate or reduce STEC to below detectable levels.

B. If IPP find that the establishment has not met the criteria in paragraph A, they are to document the noncompliance on an NR as described in FSIS Directive 5000.1, Chapter V, using the HACCP verification task and the appropriate regulatory citation (usually 9 CFR 417.5(a)(1) with the recordkeeping noncompliance classification indicator).

NOTE: IPP can verify the requirements as part of a routine scheduled HACCP verification task or, if found during performance of another task, add a directed HACCP verification task to document a noncompliance.

C. IPP are to apply a regulatory control (i.e., U.S. Retained tag) to any product produced from these incoming products when product is not going to be subjected to a lethality step as expected for product bearing an instructional or disclaimer statement.

D. If IPP retain product, they are to document the noncompliance on an NR as described in FSIS Directive 5000.1, Chapter V, using the HACCP verification task and the appropriate regulatory citation (usually 9 CFR 417.5(a)(1)). IPP are to notify the DO through supervisory channels of the conditions observed in association with the use of instructional or disclaimer statements.

IX. QUESTIONS

Refer questions regarding this directive to the Office of Policy and Program Development through askFSIS or by telephone at 1-800-233-3935. When submitting a question, use the Submit a Question tab, and enter the following information in the fields provided:

Subject Field: Enter Directive 10,010.2.
Question Field: Enter question with as much detail as possible.
Product Field: Select General Inspection Policy from the drop-down menu.
Category Field: Select Sampling – E. coli O157:H7 from the drop-down menu.
Policy Arena: Select Domestic (U.S.) Only from the drop-down menu.

When all fields are complete, press Continue and at the next screen press Finish Submitting Question.

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

Assistant Administrator
Office of Policy and Program Development

See PDF for additional information

Related Information:

• askFSIS about STEC HACCP Decision-making and Regulations
• askFSIS about STEC Labels and Statements