UPDATE TO FSIS DIRECTIVE 10,010.1, MICROBIOLOGICAL TESTING PROGRAM FOR ESCHERICHIA COLI O157:H7 IN RAW GROUND BEEF

1.  PURPOSE    

This notice provides updated instructions to inspection program personnel on some of the issues covered by FSIS Directive 10,010.1, Microbiological Testing Program for Escherichia coli O157:H7 in Raw Ground Beef. FSIS will revise FSIS Directive 10,010.1 shortly with more comprehensive procedures. In the meantime, FSIS is issuing this Notice because, based on our data, the prevalence of E. coli O157:H7 begins to rise in April and May, and the Agency needs to increase verification efforts at this time.   To the extent that FSIS Directive 10,010.1 is inconsistent with this Notice, it is superceded and revoked. 

2. BACKGROUND

On October 7, 2002, the Agency issued a Federal Register notice, E. coli O157:H7 Contamination of Beef Products, (issued to inspection program personnel as attachment 1 in FSIS Notice 44-02) that advised establishments of their obligation to reassess their HACCP plans for raw beef products. The Federal Register notice also announced the availability of guidance materials for industry and discussed revisions to be made to FSIS Directive, 10,010.1.    

3. UPDATED PROCEDURES TO REPLACE PORTIONS OF FSIS DIRECTIVE 10,010.1 

1. What are the updated procedures that are effective immediately?  

1. Inspection program personnel are to collect a raw ground beef sample whenever they receive an FSIS Form 10,210-3 for microbiological sampling project MT03, regardless of whether the establishment meets criteria set forth in FSIS Directive 10,010.1, VI.B.  All raw ground beef; hamburger; ground veal; veal or beef patties; or other products meeting the standard of identity in 9 CFR 319.15 (a-c), are eligible for verification sampling by FSIS.
   

2. Inspection program personnel are to collect samples from the current day’s production, and the samples should be, whenever possible, in their final packaged form.  Samples should not be shipped until the establishment has performed the pre-shipment review for that lot.

3. Inspection program personnel are to provide the establishment management sufficient notification of the sample collection and provide them enough time to hold the sampled lot (See FSIS Notice 47-02).  Inspection program personnel are to recommend to the establishment management that it hold the sampled lot pending the laboratory results. 

4. If a sample must be held overnight, it should be refrigerated. If a sample must be held longer than overnight, it should be frozen, as instructed in FSIS Directive 10,210.1, amendment 3, page 25, instruction 3.  Samples can be frozen regardless of day of collection, i.e., product sampled on Monday that will not have pre-shipment review completed until Wednesday morning should be frozen on Monday and shipped on Wednesday.   

5. Samples should be shipped as soon as Federal Express service is available after pre-shipment review.

6. Should a sample test positive, the establishment will be expected to take appropriate corrective and preventive action in accordance with 9 CFR 417.3.  Verification of the establishment’s corrective and preventive action may include the pulling of one or more samples from one or more lots, as determined by supervisory and inspection program personnel in the establishment.  Office of Field Operations will coordinate sampling activities with the Office of Public Health and Science.  Section VI. E. 2. of FSIS Directive 10,010.1 is revoked. 

7. Beginning with MT03 samples scheduled for collection in May 2003, information regarding production volumes of these products will be requested in Block 28 of the FSIS Form 10,210-3 for each MT03 sample.  Inspection program personnel are to provide this information based on pre-shipment clearance records maintained by the establishment as required by section 9 CFR 417.5.  Volume data are vital to the development and implementation of risk-based verification programs.  

Direct questions to the Technical Service Center.  

/s/ Philip S. Derfler

Deputy Administrator
Office of Policy and Program Development