# Presentation: 721671

## Within Establishment Public Health Risk-Based Inspection for Processing and Slaughter  

- Erin Dreyling, PhD
- Ilene D. Arnold, MS VMD
- February 5, 2008

## System Overview

- Focus inspection activities on vulnerable points
**Vulnerable point** - where the greatest microbial contamination or growth occurs if process control is not maintained
- Inspectors carry out existing inspection procedures (e.g., HACCP, SSOPS) and when prompted answer questions regarding vulnerable points
- Prompts, vulnerable points, and questions specific to each of the 9 HACCP product categories
- Observations at vulnerable points, in aggregate, may lead to an additional NR or may provide support for an enforcement action.
- Compliance guidelines and training will be developed

## Within Establishment Inspection

## System Development

- System is based upon the scientific literature and Agency experiences with HACCP and contamination events
- Literature review was used to identify vulnerable points
- FSIS experts determined inspection prompts and vulnerable point questions

## System Benefits

- Focuses on the identification of vulnerabilities within the overall food safety system
- Helps inspectors verify execution of decisions made in the hazard analysis including responding to plant data and pre-requisite programs
- Bolsters ability to link and respond to NRs and verify corrective actions are fully carried out
- Inspection results monitored automatically and alerts for anomalies built into Public Health Inspection System

## Prompt ExampleFully Cooked, Not Shelf-StableProduct

**Notes:**
9 CFR 417.2(b)(1)(vii) Fully cooked—not shelf stable.

## Prompt Description and Threshold

***Prompt Description: ***Product temperature not controlled by CCP throughout process
***Threshold: ***Two or more observations - noncompliance 03G01

## Vulnerable Points Fully Cooked, Not Shelf-Stable 

**Receiving and Storage**
**Processing**** **(e.g. mixing, rework, formulating, grinding, breading, battering, tempering, molding, solution injection, smoking, cooking, cooling)
**Storage and Shipping **

**Notes:**
*If there is sufficient evidence to demonstrate an establishment is not employing adequate controls in aggregate, then the establishment is failing to maintain sanitary conditions (416.1) or failing to implement SSOPs (416.13) and may be producing product that is injurious to health.  If there is sufficient evidence to demonstrate that an establishment is not executing a pre-requisite program identified within the hazard analysis and encompassing one or more of the vulnerable points, then the establishment is failing to properly validate that the HACCP plan is functioning as intended (417.4 (a), which brings into question whether supporting documentation for decisions in the hazard analysis are adequate (417.5 (a) (1) & (2)] and whether the Hazard Analysis is adequate (417. 2) which brings into question whether the HACCP plan is inadequate  [417.6 (a)] 
(mixing, formulating, grinding, breading, battering,
tempering, molding, solution injection, rework, smoking, cooking, cooling)  

## Receiving and Storage Questions

**Does establishment have measures to ensure materials received are wholesome and safe?  Are control measures being implemented?**
**Does plant have controls on the incoming amount of microbes on product, or adjust their processes according to incoming load?  Are controls being implemented? **
**Does the establishment have appropriate controls for returned product?  Are controls being implemented? **
**Does the establishment monitor product temperatures during storage?**

## Processing Questions

- If not a CCP, does plant achieve sufficient lethality?
- Is rework and carry-over addressed in the hazard analysis?
- Does the plant have controls in place to ensure cross contamination including different species does not occur?  Are controls being implemented?
- Does the establishment have proper procedures to follow-up positive *Listeria* (*Lm*) results on food contact surfaces or environmental samples?  Is plant carrying out follow up procedures?
- Are establishments under Alternative II or III that are using sanitation programs adequately implementing the program and controls (not SSOP; spelled out in 430)?
- Has establishment undergone recent construction and if so has it increased *Lm* monitoring? Do records show increase in *Lm* in environment?

## Storage and Receiving Questions

- Does the establishment have verifiable temperature controls in the storage?
- Does the establishment monitor conditions in storage areas that would cause adulteration of product (over spray, dripping water, etc.)?

## Potential Regulatory Outcomes

**301.2 Adulteration/ Misbranding (Meat)**
**381.1 Adulteration/ Misbranding (Poultry)**
**416.1 Failure to maintain sanitary practices**
**416.4(d) Sanitation  **
**416.13 – Implementation**
**416.13(c) SSOP for operational sanitation**
**416.14 Maintenance, Monitoring**
**417.2(a)(2) Intended Use or Consumer**
**417.5(a)(1) Hazard Analysis decisions not supported  **
**417.3(b) Unforeseen Hazard**
**430.4(b) Control of Lm in post-lethality exposed RTE product**
**424.22(a)(b) or (c) Restrictions of products that require labeling**

## Case Study: Topps Meat Company, LLC (Multistate Outbreak of E. coli O157:H7)

## 
Lack of understanding of hazards associated with E. coli O157:H7 and appropriate controls 
Lack of ability to identify problems at establishment level
Lack of support for, and sound decisions associated with, the hazard analysis
“Hazard Not Reasonably Likely to Occur” determination was not supported in hazard analysis
Lack of sufficient process controls in place and verification of appropriate implementation
Failure of Purchase Specification Program when receiving imported product 
Failure of intervention from slaughter supplying establishment which was not detected
Failure to properly identify intended use of product

- Lack of understanding of hazards associated with *E. coli* O157:H7 and appropriate controls
- Lack of ability to identify problems at establishment level
- Lack of support for, and sound decisions associated with, the hazard analysis
- “Hazard Not Reasonably Likely to Occur” determination was not supported in hazard analysis
- Lack of sufficient process controls in place and verification of appropriate implementation
- Failure of Purchase Specification Program when receiving imported product
- Failure of intervention from slaughter supplying establishment which was not detected
- Failure to properly identify intended use of product

- Case Study: Problems

## Case Study: Solutions

- Improved inspector understanding of *E. coli* O157:H7 hazard and controls
- System more closely links activities to regulatory foundation and citations to increase understanding
- System fosters inspector thinking in terms of overall food safety system to provide a broader understanding of  *E. coli* hazard
- Automated monitoring of inspection result and built-in alerts of anomalies, including a lack of inspection activity
- Also, enhanced data collection and assessment to allow more timely reaction to emerging trends
- Changes in an establishment’s HACCP plan will be identified by inspectors and will automatically send an alert
- Focuses on the identification of vulnerabilities within the overall food safety system
- Focused activities include CPs (not just CCPs) that should be addressed in prerequisite programs and SSOPs in support of the hazard analysis
- Focused verification questions address the presence and appropriate implementation of process controls
- Receiving has been identified as a potential vulnerable point; focused verification questions at that point include the use of purchase specifications
- Focused verification questions include some related to whether the product was properly marked for intended use
- Profile will include the establishment’s HACCP system; that will allow review to ensure that food safety hazards are identified and controlled