# Presentation: 692496

- Kenneth Petersen, DVM, MPH
- Assistant Administrator
- Office of Field Operations

**Food Safety Assessments for *****Escherichia Coli***** O157:H7**

## CY 2007 FSIS Recall Data

- 21 class I recalls due to *E. coli* O157:H7
- Total poundage for all 21 cases was approximately 33,358,521 lbs.
- Primarily involved ground beef, but other products were involved, e.g. pepperoni pizza and mechanically tenderized steaks.

## CY 2007 FSIS Recall Data

- The reasons for the recall were:
- 8 due to FSIS testing and the firm did not hold the sampled lot
- 3 due to industry sampling
- 10 due to illnesses

## Slide 4

## FSIS Notice 65-07

- In the October 12, 2997 Notice, FSIS directed its field personnel to:
- Conduct an awareness meeting with management officials.
- Ascertain whether and how the establishment reassessed.
- Complete *E. coli* O157:H7 checklist.

## E. Coli O157:H7 Check List

- FSIS collected information on the control measures for *E. coli* O157:H7 to:
- Identify operations that are not employing certain interrelated practices that directly contribute to the control of this pathogen.
- Capture production control practices.
- Help prioritize FSA.
- Inform the design of Risk-based verification testing.

## HACCP Size: E. coli O157:H7 Checklist

**Establishments**** ****in the *****E. coli***** O157:H7 Checklist**

| HACCP Size | Number of Establishments Represented in E. Coli Checklist | Percentage of Establishments Represented in E. Coli Checklist |
| --- | --- | --- |
| Large | 61 | 3% |
| Small | 907 | 39% |
| Very small | 1,343 | 58% |
| Other / Unknown* | 11 | <1% |
| Total | 2,322 | 100% |

- * 6 establishments have a HACCP size of ‘N’ (Not applicable) and 5 were unable to be determined through PBIS

## Food Safety Assessments (FSA) 

- In mid-November, 2007, OFO initiated FSA’s at beef producing establishments to assess the outcome of the reassessments efforts.
- OFO established criteria for prioritizing the locations for conducting these FSA.

## Criteria for Prioritizing FSA At Beef Producing Establishments

- Slaughter and/or processing with _large volume_ production.
- Small/very small _slaughter_ with _low volume._
- Small/very small that _grind_ or produce _non-intact_ steaks, etc. with _large volume_._ _
- Small/very small that _grind_ or produce _non-intact steaks_, etc. with low volume.

## Criteria for Prioritizing FSA At Beef Producing Est.  continued

- Within each category, the priority was:
- Plants that did not reassess
- Plants that reassessed within the last 6 months
- Made no changes
- Made changes to HACCP plan, prerequisite programs or SSOP with inadequate support
- No interventions or using measures that are inconsistent with the best practices

## EIAO Conducting FSA

- Enforcement Investigations and Analysis Officers (EIAO) conducted FSA’s at beef producing establishments using the prioritization criteria outlined above.
- There were 224 FSA conducted from 11/14/07 to 3/17/2008

## FSA Outcomes

**224 ****Food Safety Assessments were reported by all 15 FSIS districts .**
**34**** of the ****224 ****FSA resulted in no action and ****190**** resulted in the following FSIS action:**
**9 ****resulted in issuing a re-assessment letter requesting additional information. **
**122**** resulted in an noncompliance record (NR).**
**55 ****resulted in NOIE **
**2**** resulted in suspension**

## FSA Resulting in Enforcement Per Plant Size

| Total 224 FSA
(11/14/07 – 3/17/08) | 22 Large Plants (9.8%) | 108 Small Plants (48.2%) | 94 Very Small Plants (42%) |
| --- | --- | --- | --- |
| No. and % of NOIE  | 6 NOIE (10.9%) | 25 (45.5%) | 24 (43.6%) |
| No. and % of Suspension | 0 | 1 (50%) | 1 (50%) |

## Common Findings

- Failure to conduct hazard analysis or identify the hazards associated with key steps in the production process, e.g. mechanical tenderization step to produce non-intact cuts of beef.

## Common Findings

- Failure to provide supporting documentation for decisions on selection of CCPs and critical limits. For example why the proper concentration of lactic acid used is 2%?

## Common Findings

- Failure to carry out the monitoring and verification procedures per the prerequisite program, e.g. obtaining certificates of analysis for *E. coli* O157:H7 from suppliers and verifying their accuracy on an ongoing basis.

## Common Findings

- Failure to take appropriate corrective action as prescribed in the company's HACCP or prerequisite program. For example, failure to reject and control incoming beef trim with positive *E. coli* O157:H7.

## Common Findings

- Failure to maintain proper HACCP records to show that CCP monitoring, calibration frequencies, or corrective actions were taken appropriately according to their plans.

## Common Findings

- Failure to validate, and verify the ongoing effectiveness, of interventions designed to control E. coli O157:H7, including failure to describe procedures used in the application of the intervention.

## Common Findings

- Failure to consistently implement segregation and disposition measures to control product intended for grinding that is untested, or that tests presumptive positive or positive.

## Questions?