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CHAPTER I - GENERAL

1. PURPOSE
   1. This directive provides instructions to inspection program personnel (IPP) for collecting and submitting samples of raw beef products under FSIS' 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.
   4. FSIS is reissuing this directive to clarify that when the establishment makes ground beef patties with the same formulation as the ground beef used to make the patties (i.e., without adding additional ingredients or reducing particle size), then IPP may sample ground beef from an offline grinder instead of sampling ground beef patties (see Chapter IV Section V. D.). FSIS made no other significant changes in this revision.
   5. FSIS has added additional instructions for requesting sampling supplies for MT53_C and MT44T_C (see Chapter IV, Section III).
   6. FSIS is also clarifying that it no longer uses data from the Animal Disposition Reporting module of PHIS in the assignment of MT60_C sampling tasks.
   7. Lastly, for import inspection personnel the email for where to send a completed copy of FSIS Form 9540-1 and the foreign health certificate has changed.
      
      NOTE: For the purposes of this directive when the directive references "raw beef" it includes veal and not-ready-to-eat (NRTE) beef.
2. CANCELLATION
   FSIS Directive 10,010.1, Revision 5, Verification Activities for Escherichia coli O157:H7 in Raw Beef Products, 08/20/2015
3. 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. FSIS also tests these samples for Salmonella.
   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

1. DOMESTIC SAMPLING
2. SAMPLING FREQUENCIES FOR ROUTINE SAMPLING PROGRAMS
3. INTENDED USE AND SAMPLING ELIGIBILITY
4. IMPORT SAMPLING

CHAPTER III - PHIS PROFILE RESPONSIBILITIES

1. MANAGING THE PHIS PROFILE
2. SUPERVISORY RESPONSIBILITIES CONCERNING THE PHIS PROFILE

CHAPTER IV - SAMPLE COLLECTION PREPARATION

1. PREPARING TO COLLECT A SAMPLE OF RAW PRODUCT FOR STEC VERIFICATION TESTING
2. SCHEDULING SAMPLES IN PHIS
3. ORDERING SAMPLING SUPPLIES
4. GENERAL SAMPLING INSTRUCTION FOR ROUTINE STEC SAMPLING
5. ALTERNATIVE SAMPLING PROCEDURES FOR RAW GROUND BEEF PRODUCT (MT43) SAMPLING
6. 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
7. GATHERING SUPPLIER INFORMATION

CHAPTER V - SAMPLE COLLECTION PROCEDURES

1. GENERAL
2. FINAL PACKAGING
3. Cloth Sampling Procedure
4. N60 SAMPLING METHOD
5. ASEPTIC GRAB SAMPLING
6. PHIS QUESTIONS RELATED TO SAMPLE MATERIAL
7. PACKING AND SHIPPING THE SAMPLE
8. ACCESSING TEST RESULTS

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

1. NEGATIVE STEC TEST RESULTS
2. PRESUMPTIVE POSITIVE TEST RESULTS
3. CONFIRMED POSITIVE TEST RESULTS
4. DO RESPONSIBILITIES IN RESPONSE TO AN FSIS CONFIRMED POSITIVE TEST RESULT
5. IPP RESPONSIBILITIES AT THE ESTABLISHMENT WITH AN FSIS, ANOTHER FEDERAL, OR STATE ENTITY CONFIRMED POSITIVE TEST RESULT
6. IPP RESPONSIBILITIES ASSIGNED TO ESTABLISHMENTS THAT SUPPLIED THE SOURCE MATERIALS USED TO PRODUCE THE POSITIVE PRODUCT

CHAPTER VII - FOLLOW-UP SAMPLING PROCEDURES

1. GENERAL
2. FOLLOW-UP SAMPLING AT SUPPLIERS
3. SPECIAL INSTRUCTIONS FOR FOLLOW-UP SAMPLING (MT52_C) OF INTACT BEEF COMPONENTS THAT WERE NOT INTENDED FOR USE IN RAW NON-INTACT PRODUCT

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

1. GENERAL
2. IPP VERIFICATION RESPONSIBILITIES;
3. DO RESPONSIBILITIES IN RESPONSE TO AN AMS CONFIRMED POSITIVE TEST RESULT

CHAPTER IX- IMPORTS SAMPLING

1. DEFINITIONS FOR IMPORT SAMPLING
2. GENERAL RAW BEEF PRODUCT SAMPLING CONDUCTED AT IMPORT ESTABLISHMENTS
3. SAMPLING PROGRAM FOR IMPORTED BEEF MANUFACTUCTURING TRIMMINGS AND OTHER COMPONENTS (MT51)
4. OBTAINING SAMPLE RESULTS
5. ACTIONS TO TAKE BASED ON RESULTS

CHAPTER X - DATA ANALYSIS

OPARM will report the FSIS STEC laboratory test results for raw ground beef products, trim, and other raw ground beef components on FSIS' website and 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.

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